Clinical Utility of Silk-Elastin Sponge in Patients with Chronic and Acute Skin Ulcers: Study Protocol of a Multicenter Clinical Trial

Introduction Not only chronic but also some acute wounds have a risk of infection and become unhealed wounds. Silk-elastin sponge has been developed to treat chronic wounds that are susceptible to infection. Preclinical and clinical studies suggested that silk-elastin sponge is safe for humans and c...
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Autor*in:	Noda, Kazuo [verfasserIn] Katayama, Yasuhiro Sawaragi, Eiichi Sakamoto, Michiharu Yamanaka, Hiroki Tsuge, Itaru Katsube, Motoki Morimoto, Naoki

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2021

Schlagwörter:	Study protocol Wound healing Silk-elastin

Anmerkung:	© The Author(s) 2021

Übergeordnetes Werk:	Enthalten in: Dermatology and therapy - Heidelberg : Springer, 2011, 12(2021), 1 vom: 30. Nov., Seite 243-252
Übergeordnetes Werk:	volume:12 ; year:2021 ; number:1 ; day:30 ; month:11 ; pages:243-252

Links:	Volltext

DOI / URN:	10.1007/s13555-021-00651-4

Katalog-ID:	SPR046019758

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allfields_unstemmed	10.1007/s13555-021-00651-4 doi (DE-627)SPR046019758 (SPR)s13555-021-00651-4-e DE-627 ger DE-627 rakwb eng Noda, Kazuo verfasserin (orcid)0000-0002-6024-0888 aut Clinical Utility of Silk-Elastin Sponge in Patients with Chronic and Acute Skin Ulcers: Study Protocol of a Multicenter Clinical Trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2021 Introduction Not only chronic but also some acute wounds have a risk of infection and become unhealed wounds. Silk-elastin sponge has been developed to treat chronic wounds that are susceptible to infection. Preclinical and clinical studies suggested that silk-elastin sponge is safe for humans and can promote granulation tissue formation by reducing bacterial growth in chronic wounds. The central aim of this trial is to evaluate the clinical utility and safety of silk-elastin sponge for the treatment of chronic and acute skin ulcers. Methods This study is a prospective, multicenter, single-arm, uncontrolled clinical trial. In this study, 20 patients with chronic ulcers and five with an acute one will be included; patients with wound infection will be excluded. Silk-elastin sponges are applied and covered with a dressing for 14 days. Planned Outcomes The primary endpoint is the frequency of patients with chronic wounds in whom the investigator confirms the formation of a healthy wound bed at 14 days after the initial application of the study device. In addition, safety for acute wounds and handiness of the study device will be assessed. Trial registration number jRCT2052210072. Study protocol (dpeaa)DE-He213 Wound healing (dpeaa)DE-He213 Silk-elastin (dpeaa)DE-He213 Katayama, Yasuhiro aut Sawaragi, Eiichi aut Sakamoto, Michiharu aut Yamanaka, Hiroki aut Tsuge, Itaru aut Katsube, Motoki aut Morimoto, Naoki aut Enthalten in Dermatology and therapy Heidelberg : Springer, 2011 12(2021), 1 vom: 30. Nov., Seite 243-252 (DE-627)723900000 (DE-600)2680284-3 2190-9172 nnns volume:12 year:2021 number:1 day:30 month:11 pages:243-252 https://dx.doi.org/10.1007/s13555-021-00651-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 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_2005 GBV_ILN_2009 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 AR 12 2021 1 30 11 243-252
allfieldsGer	10.1007/s13555-021-00651-4 doi (DE-627)SPR046019758 (SPR)s13555-021-00651-4-e DE-627 ger DE-627 rakwb eng Noda, Kazuo verfasserin (orcid)0000-0002-6024-0888 aut Clinical Utility of Silk-Elastin Sponge in Patients with Chronic and Acute Skin Ulcers: Study Protocol of a Multicenter Clinical Trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2021 Introduction Not only chronic but also some acute wounds have a risk of infection and become unhealed wounds. Silk-elastin sponge has been developed to treat chronic wounds that are susceptible to infection. Preclinical and clinical studies suggested that silk-elastin sponge is safe for humans and can promote granulation tissue formation by reducing bacterial growth in chronic wounds. The central aim of this trial is to evaluate the clinical utility and safety of silk-elastin sponge for the treatment of chronic and acute skin ulcers. Methods This study is a prospective, multicenter, single-arm, uncontrolled clinical trial. In this study, 20 patients with chronic ulcers and five with an acute one will be included; patients with wound infection will be excluded. Silk-elastin sponges are applied and covered with a dressing for 14 days. Planned Outcomes The primary endpoint is the frequency of patients with chronic wounds in whom the investigator confirms the formation of a healthy wound bed at 14 days after the initial application of the study device. In addition, safety for acute wounds and handiness of the study device will be assessed. Trial registration number jRCT2052210072. Study protocol (dpeaa)DE-He213 Wound healing (dpeaa)DE-He213 Silk-elastin (dpeaa)DE-He213 Katayama, Yasuhiro aut Sawaragi, Eiichi aut Sakamoto, Michiharu aut Yamanaka, Hiroki aut Tsuge, Itaru aut Katsube, Motoki aut Morimoto, Naoki aut Enthalten in Dermatology and therapy Heidelberg : Springer, 2011 12(2021), 1 vom: 30. Nov., Seite 243-252 (DE-627)723900000 (DE-600)2680284-3 2190-9172 nnns volume:12 year:2021 number:1 day:30 month:11 pages:243-252 https://dx.doi.org/10.1007/s13555-021-00651-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 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_2005 GBV_ILN_2009 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 AR 12 2021 1 30 11 243-252
allfieldsSound	10.1007/s13555-021-00651-4 doi (DE-627)SPR046019758 (SPR)s13555-021-00651-4-e DE-627 ger DE-627 rakwb eng Noda, Kazuo verfasserin (orcid)0000-0002-6024-0888 aut Clinical Utility of Silk-Elastin Sponge in Patients with Chronic and Acute Skin Ulcers: Study Protocol of a Multicenter Clinical Trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2021 Introduction Not only chronic but also some acute wounds have a risk of infection and become unhealed wounds. Silk-elastin sponge has been developed to treat chronic wounds that are susceptible to infection. Preclinical and clinical studies suggested that silk-elastin sponge is safe for humans and can promote granulation tissue formation by reducing bacterial growth in chronic wounds. The central aim of this trial is to evaluate the clinical utility and safety of silk-elastin sponge for the treatment of chronic and acute skin ulcers. Methods This study is a prospective, multicenter, single-arm, uncontrolled clinical trial. In this study, 20 patients with chronic ulcers and five with an acute one will be included; patients with wound infection will be excluded. Silk-elastin sponges are applied and covered with a dressing for 14 days. Planned Outcomes The primary endpoint is the frequency of patients with chronic wounds in whom the investigator confirms the formation of a healthy wound bed at 14 days after the initial application of the study device. In addition, safety for acute wounds and handiness of the study device will be assessed. Trial registration number jRCT2052210072. Study protocol (dpeaa)DE-He213 Wound healing (dpeaa)DE-He213 Silk-elastin (dpeaa)DE-He213 Katayama, Yasuhiro aut Sawaragi, Eiichi aut Sakamoto, Michiharu aut Yamanaka, Hiroki aut Tsuge, Itaru aut Katsube, Motoki aut Morimoto, Naoki aut Enthalten in Dermatology and therapy Heidelberg : Springer, 2011 12(2021), 1 vom: 30. Nov., Seite 243-252 (DE-627)723900000 (DE-600)2680284-3 2190-9172 nnns volume:12 year:2021 number:1 day:30 month:11 pages:243-252 https://dx.doi.org/10.1007/s13555-021-00651-4 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 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_2005 GBV_ILN_2009 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 AR 12 2021 1 30 11 243-252
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author	Noda, Kazuo
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topic_title	Clinical Utility of Silk-Elastin Sponge in Patients with Chronic and Acute Skin Ulcers: Study Protocol of a Multicenter Clinical Trial Study protocol (dpeaa)DE-He213 Wound healing (dpeaa)DE-He213 Silk-elastin (dpeaa)DE-He213
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title	Clinical Utility of Silk-Elastin Sponge in Patients with Chronic and Acute Skin Ulcers: Study Protocol of a Multicenter Clinical Trial
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title_sort	clinical utility of silk-elastin sponge in patients with chronic and acute skin ulcers: study protocol of a multicenter clinical trial
title_auth	Clinical Utility of Silk-Elastin Sponge in Patients with Chronic and Acute Skin Ulcers: Study Protocol of a Multicenter Clinical Trial
abstract	Introduction Not only chronic but also some acute wounds have a risk of infection and become unhealed wounds. Silk-elastin sponge has been developed to treat chronic wounds that are susceptible to infection. Preclinical and clinical studies suggested that silk-elastin sponge is safe for humans and can promote granulation tissue formation by reducing bacterial growth in chronic wounds. The central aim of this trial is to evaluate the clinical utility and safety of silk-elastin sponge for the treatment of chronic and acute skin ulcers. Methods This study is a prospective, multicenter, single-arm, uncontrolled clinical trial. In this study, 20 patients with chronic ulcers and five with an acute one will be included; patients with wound infection will be excluded. Silk-elastin sponges are applied and covered with a dressing for 14 days. Planned Outcomes The primary endpoint is the frequency of patients with chronic wounds in whom the investigator confirms the formation of a healthy wound bed at 14 days after the initial application of the study device. In addition, safety for acute wounds and handiness of the study device will be assessed. Trial registration number jRCT2052210072. © The Author(s) 2021
abstractGer	Introduction Not only chronic but also some acute wounds have a risk of infection and become unhealed wounds. Silk-elastin sponge has been developed to treat chronic wounds that are susceptible to infection. Preclinical and clinical studies suggested that silk-elastin sponge is safe for humans and can promote granulation tissue formation by reducing bacterial growth in chronic wounds. The central aim of this trial is to evaluate the clinical utility and safety of silk-elastin sponge for the treatment of chronic and acute skin ulcers. Methods This study is a prospective, multicenter, single-arm, uncontrolled clinical trial. In this study, 20 patients with chronic ulcers and five with an acute one will be included; patients with wound infection will be excluded. Silk-elastin sponges are applied and covered with a dressing for 14 days. Planned Outcomes The primary endpoint is the frequency of patients with chronic wounds in whom the investigator confirms the formation of a healthy wound bed at 14 days after the initial application of the study device. In addition, safety for acute wounds and handiness of the study device will be assessed. Trial registration number jRCT2052210072. © The Author(s) 2021
abstract_unstemmed	Introduction Not only chronic but also some acute wounds have a risk of infection and become unhealed wounds. Silk-elastin sponge has been developed to treat chronic wounds that are susceptible to infection. Preclinical and clinical studies suggested that silk-elastin sponge is safe for humans and can promote granulation tissue formation by reducing bacterial growth in chronic wounds. The central aim of this trial is to evaluate the clinical utility and safety of silk-elastin sponge for the treatment of chronic and acute skin ulcers. Methods This study is a prospective, multicenter, single-arm, uncontrolled clinical trial. In this study, 20 patients with chronic ulcers and five with an acute one will be included; patients with wound infection will be excluded. Silk-elastin sponges are applied and covered with a dressing for 14 days. Planned Outcomes The primary endpoint is the frequency of patients with chronic wounds in whom the investigator confirms the formation of a healthy wound bed at 14 days after the initial application of the study device. In addition, safety for acute wounds and handiness of the study device will be assessed. Trial registration number jRCT2052210072. © The Author(s) 2021
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title_short	Clinical Utility of Silk-Elastin Sponge in Patients with Chronic and Acute Skin Ulcers: Study Protocol of a Multicenter Clinical Trial
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Clinical Utility of Silk-Elastin Sponge in Patients with Chronic and Acute Skin Ulcers: Study Protocol of a Multicenter Clinical Trial

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