General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)

Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decol...
Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Unterfrauner, Ines [verfasserIn] Bragatto-Hess, Nadja [verfasserIn] Studhalter, Thorsten [verfasserIn] Farshad, Mazda [verfasserIn] Uçkay, Ilker [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2024

Schlagwörter:	Elective orthopedic surgery High risk patients Body decolonization Surgical site infections Octenidine Questionnaire Wound problems Randomized controlled trial

Anmerkung:	© The Author(s) 2024

Übergeordnetes Werk:	Enthalten in: Trials - BioMed Central, 2000, 25(2024), 1 vom: 08. Juli
Übergeordnetes Werk:	volume:25 ; year:2024 ; number:1 ; day:08 ; month:07

Links:	Volltext

DOI / URN:	10.1186/s13063-024-08173-y

Katalog-ID:	SPR056515294

Internformat


LEADER	01000naa a22002652 4500
001	SPR056515294
003	DE-627
005	20240709064747.0
007	cr uuu---uuuuu
008	240709s2024 xx \|\|\|\|\|o 00\| \|\|eng c
024	7		\|a 10.1186/s13063-024-08173-y \|2 doi
035			\|a (DE-627)SPR056515294
035			\|a (SPR)s13063-024-08173-y-e
040			\|a DE-627 \|b ger \|c DE-627 \|e rakwb
041			\|a eng
082	0	4	\|a 610 \|q VZ
084			\|a 44.00 \|2 bkl
100	1		\|a Unterfrauner, Ines \|e verfasserin \|4 aut
245	1	0	\|a General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)
264		1	\|c 2024
336			\|a Text \|b txt \|2 rdacontent
337			\|a Computermedien \|b c \|2 rdamedia
338			\|a Online-Ressource \|b cr \|2 rdacarrier
500			\|a © The Author(s) 2024
520			\|a Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022).
650		4	\|a Elective orthopedic surgery \|7 (dpeaa)DE-He213
650		4	\|a High risk patients \|7 (dpeaa)DE-He213
650		4	\|a Body decolonization \|7 (dpeaa)DE-He213
650		4	\|a Surgical site infections \|7 (dpeaa)DE-He213
650		4	\|a Octenidine \|7 (dpeaa)DE-He213
650		4	\|a Questionnaire \|7 (dpeaa)DE-He213
650		4	\|a Wound problems \|7 (dpeaa)DE-He213
650		4	\|a Randomized controlled trial \|7 (dpeaa)DE-He213
700	1		\|a Bragatto-Hess, Nadja \|e verfasserin \|4 aut
700	1		\|a Studhalter, Thorsten \|e verfasserin \|4 aut
700	1		\|a Farshad, Mazda \|e verfasserin \|4 aut
700	1		\|a Uçkay, Ilker \|e verfasserin \|0 (orcid)0000-0002-5552-0973 \|4 aut
773	0	8	\|i Enthalten in \|t Trials \|d BioMed Central, 2000 \|g 25(2024), 1 vom: 08. Juli \|w (DE-627)326173552 \|w (DE-600)2040523-6 \|x 1745-6215 \|7 nnns
773	1	8	\|g volume:25 \|g year:2024 \|g number:1 \|g day:08 \|g month:07
856	4	0	\|u https://dx.doi.org/10.1186/s13063-024-08173-y \|m X:SPRINGER \|x Resolving-System \|z kostenfrei \|3 Volltext
912			\|a SYSFLAG_0
912			\|a GBV_SPRINGER
912			\|a SSG-OLC-PHA
912			\|a GBV_ILN_11
912			\|a GBV_ILN_20
912			\|a GBV_ILN_22
912			\|a GBV_ILN_23
912			\|a GBV_ILN_24
912			\|a GBV_ILN_39
912			\|a GBV_ILN_40
912			\|a GBV_ILN_60
912			\|a GBV_ILN_62
912			\|a GBV_ILN_63
912			\|a GBV_ILN_65
912			\|a GBV_ILN_69
912			\|a GBV_ILN_73
912			\|a GBV_ILN_74
912			\|a GBV_ILN_95
912			\|a GBV_ILN_105
912			\|a GBV_ILN_110
912			\|a GBV_ILN_151
912			\|a GBV_ILN_161
912			\|a GBV_ILN_170
912			\|a GBV_ILN_206
912			\|a GBV_ILN_213
912			\|a GBV_ILN_230
912			\|a GBV_ILN_285
912			\|a GBV_ILN_293
912			\|a GBV_ILN_602
912			\|a GBV_ILN_2003
912			\|a GBV_ILN_2005
912			\|a GBV_ILN_2009
912			\|a GBV_ILN_2011
912			\|a GBV_ILN_2014
912			\|a GBV_ILN_2055
912			\|a GBV_ILN_2111
912			\|a GBV_ILN_4012
912			\|a GBV_ILN_4037
912			\|a GBV_ILN_4112
912			\|a GBV_ILN_4125
912			\|a GBV_ILN_4126
912			\|a GBV_ILN_4249
912			\|a GBV_ILN_4305
912			\|a GBV_ILN_4306
912			\|a GBV_ILN_4307
912			\|a GBV_ILN_4313
912			\|a GBV_ILN_4322
912			\|a GBV_ILN_4323
912			\|a GBV_ILN_4324
912			\|a GBV_ILN_4325
912			\|a GBV_ILN_4338
912			\|a GBV_ILN_4367
912			\|a GBV_ILN_4700
936	b	k	\|a 44.00 \|q VZ
951			\|a AR
952			\|d 25 \|j 2024 \|e 1 \|b 08 \|c 07

Indexfelder

author_variant	i u iu n b h nbh t s ts m f mf i u iu
matchkey_str	article:17456215:2024----::eeasiadaadclnztowtotnsnebfradfeeetvotoeisreyneetdainstlvtdikorvsosreynsriastifcinaigeet
hierarchy_sort_str	2024
bklnumber	44.00
publishDate	2024
allfields	10.1186/s13063-024-08173-y doi (DE-627)SPR056515294 (SPR)s13063-024-08173-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Unterfrauner, Ines verfasserin aut General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022). Elective orthopedic surgery (dpeaa)DE-He213 High risk patients (dpeaa)DE-He213 Body decolonization (dpeaa)DE-He213 Surgical site infections (dpeaa)DE-He213 Octenidine (dpeaa)DE-He213 Questionnaire (dpeaa)DE-He213 Wound problems (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Bragatto-Hess, Nadja verfasserin aut Studhalter, Thorsten verfasserin aut Farshad, Mazda verfasserin aut Uçkay, Ilker verfasserin (orcid)0000-0002-5552-0973 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 08. Juli (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:08 month:07 https://dx.doi.org/10.1186/s13063-024-08173-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 08 07
spelling	10.1186/s13063-024-08173-y doi (DE-627)SPR056515294 (SPR)s13063-024-08173-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Unterfrauner, Ines verfasserin aut General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022). Elective orthopedic surgery (dpeaa)DE-He213 High risk patients (dpeaa)DE-He213 Body decolonization (dpeaa)DE-He213 Surgical site infections (dpeaa)DE-He213 Octenidine (dpeaa)DE-He213 Questionnaire (dpeaa)DE-He213 Wound problems (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Bragatto-Hess, Nadja verfasserin aut Studhalter, Thorsten verfasserin aut Farshad, Mazda verfasserin aut Uçkay, Ilker verfasserin (orcid)0000-0002-5552-0973 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 08. Juli (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:08 month:07 https://dx.doi.org/10.1186/s13063-024-08173-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 08 07
allfields_unstemmed	10.1186/s13063-024-08173-y doi (DE-627)SPR056515294 (SPR)s13063-024-08173-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Unterfrauner, Ines verfasserin aut General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022). Elective orthopedic surgery (dpeaa)DE-He213 High risk patients (dpeaa)DE-He213 Body decolonization (dpeaa)DE-He213 Surgical site infections (dpeaa)DE-He213 Octenidine (dpeaa)DE-He213 Questionnaire (dpeaa)DE-He213 Wound problems (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Bragatto-Hess, Nadja verfasserin aut Studhalter, Thorsten verfasserin aut Farshad, Mazda verfasserin aut Uçkay, Ilker verfasserin (orcid)0000-0002-5552-0973 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 08. Juli (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:08 month:07 https://dx.doi.org/10.1186/s13063-024-08173-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 08 07
allfieldsGer	10.1186/s13063-024-08173-y doi (DE-627)SPR056515294 (SPR)s13063-024-08173-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Unterfrauner, Ines verfasserin aut General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022). Elective orthopedic surgery (dpeaa)DE-He213 High risk patients (dpeaa)DE-He213 Body decolonization (dpeaa)DE-He213 Surgical site infections (dpeaa)DE-He213 Octenidine (dpeaa)DE-He213 Questionnaire (dpeaa)DE-He213 Wound problems (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Bragatto-Hess, Nadja verfasserin aut Studhalter, Thorsten verfasserin aut Farshad, Mazda verfasserin aut Uçkay, Ilker verfasserin (orcid)0000-0002-5552-0973 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 08. Juli (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:08 month:07 https://dx.doi.org/10.1186/s13063-024-08173-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 08 07
allfieldsSound	10.1186/s13063-024-08173-y doi (DE-627)SPR056515294 (SPR)s13063-024-08173-y-e DE-627 ger DE-627 rakwb eng 610 VZ 44.00 bkl Unterfrauner, Ines verfasserin aut General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial) 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2024 Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022). Elective orthopedic surgery (dpeaa)DE-He213 High risk patients (dpeaa)DE-He213 Body decolonization (dpeaa)DE-He213 Surgical site infections (dpeaa)DE-He213 Octenidine (dpeaa)DE-He213 Questionnaire (dpeaa)DE-He213 Wound problems (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Bragatto-Hess, Nadja verfasserin aut Studhalter, Thorsten verfasserin aut Farshad, Mazda verfasserin aut Uçkay, Ilker verfasserin (orcid)0000-0002-5552-0973 aut Enthalten in Trials BioMed Central, 2000 25(2024), 1 vom: 08. Juli (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:25 year:2024 number:1 day:08 month:07 https://dx.doi.org/10.1186/s13063-024-08173-y X:SPRINGER Resolving-System kostenfrei Volltext SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 VZ AR 25 2024 1 08 07
language	English
source	Enthalten in Trials 25(2024), 1 vom: 08. Juli volume:25 year:2024 number:1 day:08 month:07
sourceStr	Enthalten in Trials 25(2024), 1 vom: 08. Juli volume:25 year:2024 number:1 day:08 month:07
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Elective orthopedic surgery High risk patients Body decolonization Surgical site infections Octenidine Questionnaire Wound problems Randomized controlled trial
dewey-raw	610
isfreeaccess_bool	true
container_title	Trials
authorswithroles_txt_mv	Unterfrauner, Ines @@aut@@ Bragatto-Hess, Nadja @@aut@@ Studhalter, Thorsten @@aut@@ Farshad, Mazda @@aut@@ Uçkay, Ilker @@aut@@
publishDateDaySort_date	2024-07-08T00:00:00Z
hierarchy_top_id	326173552
dewey-sort	3610
id	SPR056515294
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000naa a22002652 4500</leader><controlfield tag="001">SPR056515294</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20240709064747.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">240709s2024 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s13063-024-08173-y</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR056515294</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13063-024-08173-y-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.00</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Unterfrauner, Ines</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2024</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s) 2024</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022).</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Elective orthopedic surgery</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">High risk patients</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Body decolonization</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Surgical site infections</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Octenidine</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Questionnaire</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Wound problems</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Randomized controlled trial</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Bragatto-Hess, Nadja</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Studhalter, Thorsten</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Farshad, Mazda</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Uçkay, Ilker</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-5552-0973</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Trials</subfield><subfield code="d">BioMed Central, 2000</subfield><subfield code="g">25(2024), 1 vom: 08. Juli</subfield><subfield code="w">(DE-627)326173552</subfield><subfield code="w">(DE-600)2040523-6</subfield><subfield code="x">1745-6215</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:25</subfield><subfield code="g">year:2024</subfield><subfield code="g">number:1</subfield><subfield code="g">day:08</subfield><subfield code="g">month:07</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://dx.doi.org/10.1186/s13063-024-08173-y</subfield><subfield code="m">X:SPRINGER</subfield><subfield code="x">Resolving-System</subfield><subfield code="z">kostenfrei</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_0</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_SPRINGER</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SSG-OLC-PHA</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_11</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_39</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_74</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_105</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_161</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_170</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_206</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_213</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_230</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_285</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_293</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2003</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2005</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2009</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2011</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2014</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2055</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2111</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4012</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4125</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4126</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4249</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4306</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4307</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4322</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4325</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4338</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4367</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4700</subfield></datafield><datafield tag="936" ind1="b" ind2="k"><subfield code="a">44.00</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">25</subfield><subfield code="j">2024</subfield><subfield code="e">1</subfield><subfield code="b">08</subfield><subfield code="c">07</subfield></datafield></record></collection>
author	Unterfrauner, Ines
spellingShingle	Unterfrauner, Ines ddc 610 bkl 44.00 misc Elective orthopedic surgery misc High risk patients misc Body decolonization misc Surgical site infections misc Octenidine misc Questionnaire misc Wound problems misc Randomized controlled trial General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)
authorStr	Unterfrauner, Ines
ppnlink_with_tag_str_mv	@@773@@(DE-627)326173552
format	electronic Article
dewey-ones	610 - Medicine & health
delete_txt_mv	keep
author_role	aut aut aut aut aut
collection	springer
remote_str	true
illustrated	Not Illustrated
issn	1745-6215
topic_title	610 VZ 44.00 bkl General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial) Elective orthopedic surgery (dpeaa)DE-He213 High risk patients (dpeaa)DE-He213 Body decolonization (dpeaa)DE-He213 Surgical site infections (dpeaa)DE-He213 Octenidine (dpeaa)DE-He213 Questionnaire (dpeaa)DE-He213 Wound problems (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213
topic	ddc 610 bkl 44.00 misc Elective orthopedic surgery misc High risk patients misc Body decolonization misc Surgical site infections misc Octenidine misc Questionnaire misc Wound problems misc Randomized controlled trial
topic_unstemmed	ddc 610 bkl 44.00 misc Elective orthopedic surgery misc High risk patients misc Body decolonization misc Surgical site infections misc Octenidine misc Questionnaire misc Wound problems misc Randomized controlled trial
topic_browse	ddc 610 bkl 44.00 misc Elective orthopedic surgery misc High risk patients misc Body decolonization misc Surgical site infections misc Octenidine misc Questionnaire misc Wound problems misc Randomized controlled trial
format_facet	Elektronische Aufsätze Aufsätze Elektronische Ressource
format_main_str_mv	Text Zeitschrift/Artikel
carriertype_str_mv	cr
hierarchy_parent_title	Trials
hierarchy_parent_id	326173552
dewey-tens	610 - Medicine & health
hierarchy_top_title	Trials
isfreeaccess_txt	true
familylinks_str_mv	(DE-627)326173552 (DE-600)2040523-6
title	General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)
ctrlnum	(DE-627)SPR056515294 (SPR)s13063-024-08173-y-e
title_full	General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)
author_sort	Unterfrauner, Ines
journal	Trials
journalStr	Trials
lang_code	eng
isOA_bool	true
dewey-hundreds	600 - Technology
recordtype	marc
publishDateSort	2024
contenttype_str_mv	txt
author_browse	Unterfrauner, Ines Bragatto-Hess, Nadja Studhalter, Thorsten Farshad, Mazda Uçkay, Ilker
container_volume	25
class	610 VZ 44.00 bkl
format_se	Elektronische Aufsätze
author-letter	Unterfrauner, Ines
doi_str_mv	10.1186/s13063-024-08173-y
normlink	(ORCID)0000-0002-5552-0973
normlink_prefix_str_mv	(orcid)0000-0002-5552-0973
dewey-full	610
author2-role	verfasserin
title_sort	general skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (balgdec trial)
title_auth	General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)
abstract	Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022). © The Author(s) 2024
abstractGer	Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022). © The Author(s) 2024
abstract_unstemmed	Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022). © The Author(s) 2024
collection_details	SYSFLAG_0 GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700
container_issue	1
title_short	General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)
url	https://dx.doi.org/10.1186/s13063-024-08173-y
remote_bool	true
author2	Bragatto-Hess, Nadja Studhalter, Thorsten Farshad, Mazda Uçkay, Ilker
author2Str	Bragatto-Hess, Nadja Studhalter, Thorsten Farshad, Mazda Uçkay, Ilker
ppnlink	326173552
mediatype_str_mv	c
isOA_txt	true
hochschulschrift_bool	false
doi_str	10.1186/s13063-024-08173-y
up_date	2024-07-10T07:13:17.881Z
_version_	1804175249646813184
fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000naa a22002652 4500</leader><controlfield tag="001">SPR056515294</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20240709064747.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">240709s2024 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s13063-024-08173-y</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR056515294</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13063-024-08173-y-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.00</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Unterfrauner, Ines</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2024</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s) 2024</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022).</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Elective orthopedic surgery</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">High risk patients</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Body decolonization</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Surgical site infections</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Octenidine</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Questionnaire</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Wound problems</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Randomized controlled trial</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Bragatto-Hess, Nadja</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Studhalter, Thorsten</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Farshad, Mazda</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Uçkay, Ilker</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-5552-0973</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Trials</subfield><subfield code="d">BioMed Central, 2000</subfield><subfield code="g">25(2024), 1 vom: 08. Juli</subfield><subfield code="w">(DE-627)326173552</subfield><subfield code="w">(DE-600)2040523-6</subfield><subfield code="x">1745-6215</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:25</subfield><subfield code="g">year:2024</subfield><subfield code="g">number:1</subfield><subfield code="g">day:08</subfield><subfield code="g">month:07</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://dx.doi.org/10.1186/s13063-024-08173-y</subfield><subfield code="m">X:SPRINGER</subfield><subfield code="x">Resolving-System</subfield><subfield code="z">kostenfrei</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_0</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_SPRINGER</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SSG-OLC-PHA</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_11</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_20</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_22</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_23</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_24</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_39</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_40</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_60</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_62</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_63</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_65</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_69</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_73</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_74</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_95</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_105</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_110</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_151</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_161</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_170</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_206</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_213</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_230</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_285</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_293</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_602</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2003</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2005</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2009</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2011</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2014</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2055</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_2111</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4012</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4037</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4112</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4125</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4126</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4249</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4305</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4306</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4307</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4313</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4322</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4323</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4324</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4325</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4338</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4367</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_ILN_4700</subfield></datafield><datafield tag="936" ind1="b" ind2="k"><subfield code="a">44.00</subfield><subfield code="q">VZ</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">25</subfield><subfield code="j">2024</subfield><subfield code="e">1</subfield><subfield code="b">08</subfield><subfield code="c">07</subfield></datafield></record></collection>
score	7.3996916

Nicht das Richtige dabei?

Schreiben Sie uns!

General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)

Nicht das Richtige dabei?

Zugang & Verfügbarkeit

Vorhandene Bände

Nicht das Richtige dabei?