Brown, Anneke, Augustin, Matthias, Juenger, Michael, Zutt, Markus, Dissemond, Joachim, Rabe, Eberhard, Kaufmann, Roland, Simon, Margrit, Stuecker, Markus, Karrer, Sigrid, Koenen, Wolfgang, Vanscheidt, Wolfgang, Scharfetter-Kochanek, Karin, Wollina, Uwe ORCID: 0000-0001-5933-2913, Krieg, Thomas and Eming, Sabine A. (2014). Randomized standard-of-care-controlled trial of a silica gel fibre matrix in the treatment of chronic venous leg ulcers. Eur. J. Dermatol., 24 (2). S. 210 - 217. MONTROUGE: JOHN LIBBEY EUROTEXT LTD. ISSN 1952-4013

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Abstract

Background: Chronic venous leg ulcers (CVU) are a common, unresolved medical problem. Silica gel fibre (SGF) is a novel biodegradable inorganic material developed to serve as a carrier substrate for the local release of pharmaceutical agents facilitating tissue repair. Objectives: To assess the performance and safety of SGF in subjects with CVU. Methods: Open, randomized, standard-of-care-controlled, multi-centre trial. Subjects (ITT 120 patients) received either SGF in addition to standard treatment or standard-of-care treatment (S-o-C) alone. The primary performance variable was the time to healing of the target ulcer until the end of a 12 week treatment period. Results: SGF was well tolerated. Mean time to healing up to week 12 was 85.62 days for the SGF group (SE +/- 1.5) and 79.66 days for the S-o-C group (SE +/- 1.77) (p-value = 0.217). There was no statistically relevant difference regarding the incidence of complete healing of the target ulcers by weeks 12 and 24 between the SGF and the S-o-C groups (p-value >0.05). Conclusion: SGF is well tolerated and offers a promising perspective as a carrier substrate for the local release of active pharmaceutical agents into the wound site to promote tissue repair.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Brown, AnnekeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Augustin, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Juenger, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zutt, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dissemond, JoachimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rabe, EberhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaufmann, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Simon, MargritUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stuecker, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Karrer, SigridUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koenen, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vanscheidt, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scharfetter-Kochanek, KarinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wollina, UweUNSPECIFIEDorcid.org/0000-0001-5933-2913UNSPECIFIED
Krieg, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eming, Sabine A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-443717
DOI: 10.1684/ejd.2014.2344
Journal or Publication Title: Eur. J. Dermatol.
Volume: 24
Number: 2
Page Range: S. 210 - 217
Date: 2014
Publisher: JOHN LIBBEY EUROTEXT LTD
Place of Publication: MONTROUGE
ISSN: 1952-4013
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
BIOMATERIALS; DEBRIDEMENT; DRESSINGS; FOOTMultiple languages
DermatologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/44371

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