The effects of cadexomer iodine paste in the treatment of venous leg ulcers compared with hydrocolloid dressing and paraffin gauze dressing. Cadexomer Iodine Study Group.

Background: The aim was to examine cadexomer iodine paste in a comparative clinical trial.

Methods: A 12-week, randomized, open, controlled, multicenter, multinational trial in patients with exudating, venous leg ulcers of cadexomer iodine paste (Iodosorb/Iodoflex), hydrocolloid dressing (Duoderm E, Granuflex E), or paraffin gauze dressing (Jelonet) was carried out. All patients used short-stretch compression bandages (Comprilan) throughout the study. The primary efficacy variable was a reduction in ulcer size (%), and the secondary end-point was the time taken to stop exudation, when the patient had completed the study according to the protocol. A total of 153 patients entered the study and were treated for 12 weeks or until cessation of exudation.

Results: The mean reduction in ulcer size in all patients was 62% with cadexomer iodine vs. 41% and 24% for hydrocolloid and paraffin gauze (ns). Of those treated for 12 weeks (n = 51), ulcer area reduction was 66% for cadexomer iodine and 18% for hydrocolloid (p = 0.0127). For the whole material, the rate of healing (ulcer area reduction per week) was significantly higher for cadexomer iodine than for paraffin gauze (0.64 cm2/week vs. 0.19 cm2/week, p = 0.0353). The treatment costs were similar in all groups; however, when the costs were correlated with healing over a 12-week period, cadexomer iodine paste was found to be more cost effective than hydrocolloid dressing or paraffin gauze dressing.

Conclusions: This study shows that cadexomer iodine paste is an efficient, cost-effective and safe alternative to hydrocolloid dressing and paraffin gauze dressing for the treatment of venous leg ulcers.