Universität zu Köln

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:	Creators Email ORCID ORCID Put Code Brown, Anneke UNSPECIFIED UNSPECIFIED UNSPECIFIED Augustin, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Juenger, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Zutt, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Dissemond, Joachim UNSPECIFIED UNSPECIFIED UNSPECIFIED Rabe, Eberhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaufmann, Roland UNSPECIFIED UNSPECIFIED UNSPECIFIED Simon, Margrit UNSPECIFIED UNSPECIFIED UNSPECIFIED Stuecker, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Karrer, Sigrid UNSPECIFIED UNSPECIFIED UNSPECIFIED Koenen, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Vanscheidt, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Scharfetter-Kochanek, Karin UNSPECIFIED UNSPECIFIED UNSPECIFIED Wollina, Uwe UNSPECIFIED orcid.org/0000-0001-5933-2913 UNSPECIFIED Krieg, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Eming, Sabine A. UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language BIOMATERIALS; DEBRIDEMENT; DRESSINGS; FOOT Multiple languages Dermatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/44371