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A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan

Stahl, Hans-Christian ; Ahmadi, Faridullah ; Schleicher, Ulrike ; Sauerborn, Rainer ; Bermejo, Justo Lorenzo ; Amirih, Mohammed Latif ; Sakhayee, Ibrahim ; Bogdan, Christian ; Stahl, Kurt-Wilhelm

In: BMC Infectious Diseases, 14 (2014), Nr. 619. pp. 1-12. ISSN 1471-2334

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Download (533kB) | Lizenz: Creative Commons LizenzvertragA randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan by Stahl, Hans-Christian ; Ahmadi, Faridullah ; Schleicher, Ulrike ; Sauerborn, Rainer ; Bermejo, Justo Lorenzo ; Amirih, Mohammed Latif ; Sakhayee, Ibrahim ; Bogdan, Christian ; Stahl, Kurt-Wilhelm underlies the terms of Creative Commons Attribution 3.0 Germany

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Abstract

Background: A previously published proof of principle phase IIa trial with 113 patients from Kabul showed that bipolar high-frequency (HF) electro-cauterization (EC) of cutaneous leishmaniasis (CL) ulcers and subsequent moist wound treatment (MWT) closed 85% of all Leishmania (L.) tropica lesions within 60 days. Methods: A three-armed phase IIb, randomized and controlled clinical trial was performed in Mazar-e-Sharif. L. tropica- or L. major-infected CL patients received intradermal sodium stibogluconate (SSG) (Group I); HF-EC followed by MWT with 0.045% DAC N-055 (Group II); or MWT with 0.045% DAC N-055 in basic crème alone (Group III). The primary outcome was complete epithelialisation before day 75 after treatment start. Results: 87 patients enrolled in the trial were randomized into group I (n = 24), II (n = 32) and III (n = 31). The per-protocol analysis of 69 (79%) patients revealed complete epithelialisation before day 75 in 15 (of 23; 65%) patients of Group I, in 23 (of 23; 100%) patients of Group II, and in 20 (of 23; 87%) patients of Group III (p = 0.004, Fisher’s Exact Test). In the per-protocol analysis, wound closure times were significantly different between all regimens in a pair-wise comparison (p = 0.000039, Log-Rank (Mantel-Cox) test). In the intention-to-treat analysis wound survival times in Group II were significantly different from those in Group I (p = 0.000040, Log-Rank (Mantel-Cox) test). Re-ulcerations occurred in four (17%), three (13%) and seven (30%) patients of Group I, II or III, respectively (p = 0.312, Pearson Chi-Square Test). Conclusions: Treatment of CL ulcers with bipolar HF-EC followed by MWT with 0.045% DAC N-055 or with DAC N-055 alone showed shorter wound closure times than with the standard SSG therapy. The results merit further exploration in larger trials in the light of our current knowledge of in vitro and in vivo activities of chlorite. Clinicaltrials.gov ID: NCT00996463. Registered: 15th October 2009.

Item Type: Article
Journal or Publication Title: BMC Infectious Diseases
Volume: 14
Number: 619
Publisher: BioMed Central; Springer
Place of Publication: London; Berlin; Heidelberg
Date Deposited: 09 Jun 2016 09:46
Date: 2014
ISSN: 1471-2334
Page Range: pp. 1-12
Faculties / Institutes: Medizinische Fakultät Heidelberg > Institut für Medizinische Biometrie und Informatik
Medizinische Fakultät Heidelberg > Institut für Public Health (IPH)
Subjects: 610 Medical sciences Medicine
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