Cellulose biomembrane versus collagenase dressing for the treatment of chronic venous ulcers: a randomized, controlled clinical trial

Detalhes bibliográficos
Autor(a) principal: Colenci, Raquel [UNESP]
Data de Publicação: 2019
Outros Autores: Miot, Hélio A. [UNESP], Marques, Mariângela E. A. [UNESP], Schmitt, Juliano V. [UNESP], Basmaji, Pierre, Jacinto, Jéssica dos Santos [UNESP], Abbade, Luciana P. F. [UNESP]
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.1684/ejd.2019.3608
http://hdl.handle.net/11449/199517
Resumo: Background: Cellulose biomembranes may be used for difficult-to-treat ulcers. Objectives: To assess the efficacy and safety of cellulose biomem-branes compared to a collagenase dressing for the treatment of chronic venous ulcers. Materials and Methods: A randomized, controlled clinical trial was performed using two groups: one treated with collagenase dressing and the other with cellulose biomembrane over a 90-day (T90) period. Both groups received compression therapy. The primary outcome was reduction in ulcer area at T90. Secondary outcomes were healing status, decrease in devitalized tissue and exudate, vascular fraction, change in quality of life, and safety. Results: We randomized 46 participants with 73 venous ulcers (21 with 36 ulcers in the collagenase group and 25 with 37 ulcers in the biomembrane group). A decrease in ulcer area occurred at T90 in both groups, but the difference was not significant. Complete healing before T90 occurred for seven ulcers in the collagenase group and 12 ulcers in the biomembrane group, without significant difference. However, the biomembrane promoted increased precocious healing (p = 0.02). Improved bed vitality and quality of life was observed as a function of time (p <. 0.01), but this was not significant between the groups. Immunohistochemical analysis of CD34 showed an increase in vascular fraction in both groups (p< 0.01), with a higher level in the biomembrane group (p < 0.05). No adverse events were considered related to the products. Conclusion: Cellulose biomem-branes, in combination with compressive therapy, are effective and safe for the treatment of venous ulcers and provide results similar to those with collagenase treatment.
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spelling Cellulose biomembrane versus collagenase dressing for the treatment of chronic venous ulcers: a randomized, controlled clinical trialcellulose biomembranechronic venous ulcerclinical trialcollagenasetherapyBackground: Cellulose biomembranes may be used for difficult-to-treat ulcers. Objectives: To assess the efficacy and safety of cellulose biomem-branes compared to a collagenase dressing for the treatment of chronic venous ulcers. Materials and Methods: A randomized, controlled clinical trial was performed using two groups: one treated with collagenase dressing and the other with cellulose biomembrane over a 90-day (T90) period. Both groups received compression therapy. The primary outcome was reduction in ulcer area at T90. Secondary outcomes were healing status, decrease in devitalized tissue and exudate, vascular fraction, change in quality of life, and safety. Results: We randomized 46 participants with 73 venous ulcers (21 with 36 ulcers in the collagenase group and 25 with 37 ulcers in the biomembrane group). A decrease in ulcer area occurred at T90 in both groups, but the difference was not significant. Complete healing before T90 occurred for seven ulcers in the collagenase group and 12 ulcers in the biomembrane group, without significant difference. However, the biomembrane promoted increased precocious healing (p = 0.02). Improved bed vitality and quality of life was observed as a function of time (p <. 0.01), but this was not significant between the groups. Immunohistochemical analysis of CD34 showed an increase in vascular fraction in both groups (p< 0.01), with a higher level in the biomembrane group (p < 0.05). No adverse events were considered related to the products. Conclusion: Cellulose biomem-branes, in combination with compressive therapy, are effective and safe for the treatment of venous ulcers and provide results similar to those with collagenase treatment.Nursing Department Botucatu Medical School/UNESPDermatology and Radiotherapy Department Botucatu Medical School/UNESPPathology Department Botucatu Medical School/UNESPInnovatecs Center for Research and Biotechnological DevelopmentNursing Department Botucatu Medical School/UNESPDermatology and Radiotherapy Department Botucatu Medical School/UNESPPathology Department Botucatu Medical School/UNESPUniversidade Estadual Paulista (Unesp)Innovatecs Center for Research and Biotechnological DevelopmentColenci, Raquel [UNESP]Miot, Hélio A. [UNESP]Marques, Mariângela E. A. [UNESP]Schmitt, Juliano V. [UNESP]Basmaji, PierreJacinto, Jéssica dos Santos [UNESP]Abbade, Luciana P. F. [UNESP]2020-12-12T01:42:03Z2020-12-12T01:42:03Z2019-07-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article387-395http://dx.doi.org/10.1684/ejd.2019.3608European Journal of Dermatology, v. 29, n. 4, p. 387-395, 2019.1952-40131167-1122http://hdl.handle.net/11449/19951710.1684/ejd.2019.36082-s2.0-85073583718Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengEuropean Journal of Dermatologyinfo:eu-repo/semantics/openAccess2024-09-03T13:18:43Zoai:repositorio.unesp.br:11449/199517Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestrepositoriounesp@unesp.bropendoar:29462024-09-03T13:18:43Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Cellulose biomembrane versus collagenase dressing for the treatment of chronic venous ulcers: a randomized, controlled clinical trial
title Cellulose biomembrane versus collagenase dressing for the treatment of chronic venous ulcers: a randomized, controlled clinical trial
spellingShingle Cellulose biomembrane versus collagenase dressing for the treatment of chronic venous ulcers: a randomized, controlled clinical trial
Colenci, Raquel [UNESP]
cellulose biomembrane
chronic venous ulcer
clinical trial
collagenase
therapy
title_short Cellulose biomembrane versus collagenase dressing for the treatment of chronic venous ulcers: a randomized, controlled clinical trial
title_full Cellulose biomembrane versus collagenase dressing for the treatment of chronic venous ulcers: a randomized, controlled clinical trial
title_fullStr Cellulose biomembrane versus collagenase dressing for the treatment of chronic venous ulcers: a randomized, controlled clinical trial
title_full_unstemmed Cellulose biomembrane versus collagenase dressing for the treatment of chronic venous ulcers: a randomized, controlled clinical trial
title_sort Cellulose biomembrane versus collagenase dressing for the treatment of chronic venous ulcers: a randomized, controlled clinical trial
author Colenci, Raquel [UNESP]
author_facet Colenci, Raquel [UNESP]
Miot, Hélio A. [UNESP]
Marques, Mariângela E. A. [UNESP]
Schmitt, Juliano V. [UNESP]
Basmaji, Pierre
Jacinto, Jéssica dos Santos [UNESP]
Abbade, Luciana P. F. [UNESP]
author_role author
author2 Miot, Hélio A. [UNESP]
Marques, Mariângela E. A. [UNESP]
Schmitt, Juliano V. [UNESP]
Basmaji, Pierre
Jacinto, Jéssica dos Santos [UNESP]
Abbade, Luciana P. F. [UNESP]
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidade Estadual Paulista (Unesp)
Innovatecs Center for Research and Biotechnological Development
dc.contributor.author.fl_str_mv Colenci, Raquel [UNESP]
Miot, Hélio A. [UNESP]
Marques, Mariângela E. A. [UNESP]
Schmitt, Juliano V. [UNESP]
Basmaji, Pierre
Jacinto, Jéssica dos Santos [UNESP]
Abbade, Luciana P. F. [UNESP]
dc.subject.por.fl_str_mv cellulose biomembrane
chronic venous ulcer
clinical trial
collagenase
therapy
topic cellulose biomembrane
chronic venous ulcer
clinical trial
collagenase
therapy
description Background: Cellulose biomembranes may be used for difficult-to-treat ulcers. Objectives: To assess the efficacy and safety of cellulose biomem-branes compared to a collagenase dressing for the treatment of chronic venous ulcers. Materials and Methods: A randomized, controlled clinical trial was performed using two groups: one treated with collagenase dressing and the other with cellulose biomembrane over a 90-day (T90) period. Both groups received compression therapy. The primary outcome was reduction in ulcer area at T90. Secondary outcomes were healing status, decrease in devitalized tissue and exudate, vascular fraction, change in quality of life, and safety. Results: We randomized 46 participants with 73 venous ulcers (21 with 36 ulcers in the collagenase group and 25 with 37 ulcers in the biomembrane group). A decrease in ulcer area occurred at T90 in both groups, but the difference was not significant. Complete healing before T90 occurred for seven ulcers in the collagenase group and 12 ulcers in the biomembrane group, without significant difference. However, the biomembrane promoted increased precocious healing (p = 0.02). Improved bed vitality and quality of life was observed as a function of time (p <. 0.01), but this was not significant between the groups. Immunohistochemical analysis of CD34 showed an increase in vascular fraction in both groups (p< 0.01), with a higher level in the biomembrane group (p < 0.05). No adverse events were considered related to the products. Conclusion: Cellulose biomem-branes, in combination with compressive therapy, are effective and safe for the treatment of venous ulcers and provide results similar to those with collagenase treatment.
publishDate 2019
dc.date.none.fl_str_mv 2019-07-01
2020-12-12T01:42:03Z
2020-12-12T01:42:03Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1684/ejd.2019.3608
European Journal of Dermatology, v. 29, n. 4, p. 387-395, 2019.
1952-4013
1167-1122
http://hdl.handle.net/11449/199517
10.1684/ejd.2019.3608
2-s2.0-85073583718
url http://dx.doi.org/10.1684/ejd.2019.3608
http://hdl.handle.net/11449/199517
identifier_str_mv European Journal of Dermatology, v. 29, n. 4, p. 387-395, 2019.
1952-4013
1167-1122
10.1684/ejd.2019.3608
2-s2.0-85073583718
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv European Journal of Dermatology
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 387-395
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv repositoriounesp@unesp.br
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