Covering skin defects with a xenogeneic collagen matrix in comparison with a skin graft - A multicenter randomized controlled trial.


Journal

Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery
ISSN: 1878-4119
Titre abrégé: J Craniomaxillofac Surg
Pays: Scotland
ID NLM: 8704309

Informations de publication

Date de publication:
Jan 2024
Historique:
received: 09 05 2023
revised: 03 10 2023
accepted: 16 10 2023
medline: 4 7 2024
pubmed: 4 7 2024
entrez: 4 7 2024
Statut: ppublish

Résumé

The objective of this study was to analyze, in a randomized controlled multicenter trial, whether a xenogeneic collagen matrix (XCM) could be used to cover skin defects. Patients with the need for skin excisions were recruited and randomized to treatment with a skin graft after a period of granulation or to treatment with an XCM. The results were evaluated by two independent observers on the Patient and Observer Scar Assessment Scale. On this scale, scars are ranked from 1 to 10 in six different categories. Results range from 6 to 60, with lower scores representing scars closer to normal skin. The results 6 months after reconstruction were used as primary endpoint and compared in a non-inferiority approach. A total of 39 wounds in the head and neck region were analyzed. The mean results were 16.55 (standard deviation 6.8) for XCM and 16.83 (standard deviation 8.21) in the control group. The result of the XCM was not significantly inferior to the result of the skin graft (p = 0.91). Within the limitations of the study, it seems that the use of xenogeneic collagen matrices is a viable alternative to other approaches in small skin defects, and therefore should be taken into account whenever the reduction of patient morbidity to a minimum is the priority. TRIAL REGISTRATION: This trial was registered in the German Clinical Trials Register under registration identification number DRKS00010930 and can be found under the following URLs: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010930. https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00010930.

Identifiants

pubmed: 38962824
pii: S1010-5182(23)00199-3
doi: 10.1016/j.jcms.2023.10.009
pii:
doi:

Substances chimiques

Collagen 9007-34-5

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Comparative Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

101-107

Informations de copyright

Copyright © 2023 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Kai Wermker (K)

Department of Oral and Cranio-Maxillofacial Surgery, Klinikum Osnabrueck GmbH, Am Finkenhuegel 1, 49076 Osnabrueck, Germany.

Max Hogrebe (M)

Department of Oral and Cranio-Maxillofacial Surgery, Fachklinik Hornheide, Dorbaumstrasse 300, 48157 Muenster, Germany. Electronic address: max.hogrebe@gmail.com.

Nils-Claudius Gellrich (NC)

Department of Oral and Cranio-Maxillofacial Surgery, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany.

Anja Heselich (A)

Department of Oral and Cranio-Maxillofacial Surgery, Medical Center of the Goethe University Frankfurt, Theodor-Stern-Kai 7, 60596 Frankfurt Am Main, Germany.

Shahram Ghanaati (S)

Department of Oral and Cranio-Maxillofacial Surgery, Medical Center of the Goethe University Frankfurt, Theodor-Stern-Kai 7, 60596 Frankfurt Am Main, Germany.

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Classifications MeSH