A randomised controlled trial on the effectiveness of an advanced wound dressing used in Iran

Abstract

Objective: To compare the wound healing rate and incidence of infection in wounds treated with either a bioactive dressing (containing hydrophilic mucopolysaccharide, chitosan) or conservative treatment (gauze).

Method: Eighty-five patients with diabetic foot ulcers, pressure ulcers or leg ulcers were randomised to receive either the bioactive study dressing (n=33 patients, 45 wounds) or the control dressing (n=52 patients, 53 wounds) for 21 days. Wound size, stage where appropriate and the presence of infection were recorded at each dressing change. Thirty-one of these 85 patients dropped out of the study during the three-month post-treatment follow-up, when wound size and grade were assessed on a monthly basis. Data were therefore analysed on 54 patients, of whom 32 (34 wounds) were in the treatment group and 22 (26 wounds) in the control group.

Results: In the control group, four pressure ulcers healed, but the remaining wounds all deteriorated and became infected, requiring antibiotics. In contrast, in the treatment group 29/34 wounds healed completely, and none became infected; the remaining five wounds healed during the follow-up period. The difference between the two groups in the number of wounds that healed was statistically significant (p<0.001), as was that for the number of healed pressure ulcers p<0.05.

Conclusion: Use of a moist bioactive wound dressing significantly increased the healing rate when compared with the traditional dressings used in the participating hospitals. This will in turn bring significant cost savings.