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
Autor*in: |
Unterfrauner, Ines [verfasserIn] Bragatto-Hess, Nadja [verfasserIn] Studhalter, Thorsten [verfasserIn] Farshad, Mazda [verfasserIn] Uçkay, Ilker [verfasserIn] |
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E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2024 |
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Schlagwörter: |
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Anmerkung: |
© The Author(s) 2024 |
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Übergeordnetes Werk: |
Enthalten in: Trials - BioMed Central, 2000, 25(2024), 1 vom: 08. Juli |
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Übergeordnetes Werk: |
volume:25 ; year:2024 ; number:1 ; day:08 ; month:07 |
Links: |
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DOI / URN: |
10.1186/s13063-024-08173-y |
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Katalog-ID: |
SPR056515294 |
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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) |
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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). | ||
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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 |
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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 |
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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 |
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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 |
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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 |
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container_issue |
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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 |
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Bragatto-Hess, Nadja Studhalter, Thorsten Farshad, Mazda Uçkay, Ilker |
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doi_str |
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up_date |
2024-07-10T07:13:17.881Z |
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