Brown, Anneke and Augustin, Matthias and Juenger, Michael and Zutt, Markus and Dissemond, Joachim and Rabe, Eberhard and Kaufmann, Roland and Simon, Margrit and Stuecker, Markus and Karrer, Sigrid and Koenen, Wolfgang and Vanscheidt, Wolfgang and Scharfetter-Kochanek, Karin and Wollina, Uwe and 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. EUROPEAN JOURNAL OF DERMATOLOGY, 24 (2). pp. 210-216. ISSN 1167-1122, 1952-4013
Full text not available from this repository. (Request a copy)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: | Article |
|---|---|
| Uncontrolled Keywords: | BIOMATERIALS; DEBRIDEMENT; DRESSINGS; FOOT; biodegradable matrix; silica gel fibre matrix; venous ulcer |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Dermatologie und Venerologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 18 Nov 2019 09:38 |
| Last Modified: | 18 Nov 2019 09:38 |
| URI: | https://pred.uni-regensburg.de/id/eprint/10489 |
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