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Randomized Controlled Trial
. 2013 Jun 24;8(6):e66123.
doi: 10.1371/journal.pone.0066123. Print 2013.

Dressings combined with injection of meglumine antimoniate in the treatment of cutaneous leishmaniasis: a randomized controlled clinical trial

Alireza Khatami  1 , Rezvan Talaee, Makan Rahshenas, Ali Khamesipour, Pedram Mehryan, Sepideh Tehrani, Yahya Dowlati, Alireza Firooz
Affiliations
Randomized Controlled Trial

Dressings combined with injection of meglumine antimoniate in the treatment of cutaneous leishmaniasis: a randomized controlled clinical trial

Alireza Khatami et al. PLoS One. .

Abstract

Background: Cutaneous leishmaniasis (CL) is a neglected infectious disease and a major health problem in several developing countries. Despite some reasonable explanation for their potential benefits, there is only trace evidence regarding the role of dressings in the treatment of CL.

Methods: This randomized, assessor-blind, controlled, clinical trial was conducted in an endemic area for CL caused by Leishmania major in Iran to assess the efficacy of administration of weekly intralesional meglumine antimoniate (i.l.MA) either alone or combined with application of a silver or a non-silver polyester dressing on their lesions for 6 weeks. After screening of 241 patients with CL lesions, 83 eligible patients with 158 lesions were randomly allocated in three arms of the study. Eligibility criteria included parasitologically confirmed CL, age of 12 to 60 years; willingness to participate, duration of lesion<3 months, number of lesions<5, largest ulcer diameter<5 cm. Pregnant or lactating women were excluded. The primary outcome was absolute risk reduction (ARR) based on the proportion of complete healing, which was defined as more than 75% reduction in the size of the lesion compared with baseline in each group at the termination of treatment and 1 month later.

Findings: ARR (95% Confidence Interval [CI]) in i.l.MA versus i.l.MA+non-silver dressing groups was 5.98% (-7.07% to 20.25%), between i.l.MA versus i.l.MA+silver dressing groups was -0.23% (-13.53% to 14.82%), and between i.l.MA+non-silver dressing versus i.l.MA+silver dressing groups was -6.21%(-18.28% to 6.52%) after 6 weeks of treatment. ARR (95% CI) in i.l.MA versus i.l.MA+non-silver dressing groups was -2.22% (-22.12% to 18.10%), between i.l.MA versus i.l.MA+silver dressing groups was 3.64% (-15.36% to 22.82%), and between i.l.MA+non-silver dressing versus i.l.MA+silver dressing groups was 5.86% (-12.86% to 24.31%) 1 month later.

Conclusion: It could not be demonstrated that the efficacy of i.l.MA was improved by either dressing.

Trial registration: Iranian Registry of Clinical Trials (IRCT.ir) IRCT138707201166N2.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Patients' disposition flow diagram (CONSORT flowchart) from day 0 to day 72 (4 weeks after termination of treatment).
See this image and copyright information in PMC

References

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