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HERO ID
7468116
Reference Type
Journal Article
Title
Efficacy of Cadexomer Iodine in the Treatment of Chronic Ulcers: A Randomized, Multicenter, Controlled Trial
Author(s)
Raju, R; Kethavath, SN; Sangavarapu, SM; Kanjarla, P
Year
2019
Volume
31
Issue
3
Page Numbers
85-90
Language
English
PMID
30720444
Abstract
INTRODUCTION:
Due to being hard to heal, chronic ulcers account for high morbidity.
OBJECTIVE:
This study compares the safety and efficacy of 2 formulations of cadexomer iodine and standard care for the treatment of chronic ulcers.
MATERIALS AND METHODS:
This prospective, randomized, open-label clinical trial was conducted at 8 cities across 15 institutions in India from March 2016 to March 2017. After screening a total of 145 patients with chronic, recalcitrant ulcers, 124 were randomized to 1 of 3 treatments: 0.9% cadexomer iodine ointment plus standard care (n = 41), 0.9% cadexomer iodine powder plus standard care (n = 43), and standard care alone (n = 40). All patients completed the maximum treatment period of 12 weeks, with the exception of 8 who discontinued during the study period. At the end of the treatment period, endpoints were assessed.
RESULTS:
The percentage of reduction in ulcer size from baseline to the primary endpoint of 12 weeks was significantly higher with both formulations of cadexomer iodine ointment (94.3% ± 10.6%) and powder (90.4% ± 14.9%) as compared with standard care alone (67.8% ± 21.8%). The percentage of patients with complete wound healing at the end of the 12 weeks was significantly higher in patients treated with both formulations of cadexomer iodine ointment (65.8%) and powder (58.1%) as compared with standard care alone (20.0%).
CONCLUSIONS:
These results demonstrate that cadexomer iodine, in comparison with standard care alone, increases the percentage of reduction in ulcer size and promotes complete wound healing in chronic ulcers.
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