Effectiveness of two bundles in venous leg ulcer healing: A randomized controlled trial

Abstract

The objective of this study was to compare the effectiveness of 2 bundles in venous leg ulcer healing. This study is a open, randomized, controlled clinical trial with parallel treatment, 1:1 allocation rate, and 24-week follow-up. Twenty-eight patients with venous leg ulcers of the lower limbs were allocated to 2 groups: group A (n = 14) and group B (n = 14). The mean age of the participants was 59.67 ± 11.95 years, and the mean ulcer surface area was 29.32 (±98.43) cm². The primary outcome was ulcer healing. Secondary outcomes were wound area reduction rate, Pressure Ulcer Scale of Healing (PUSH) scores, and the presence and intensity of pain before, during and after dressing change. Two different bundles were applied in 2 phases to the randomized groups. All participants engaged in an educational activity, performed exercises, rested with legs elevated, received oral nutrition supplementation (Cubitan; Danone Nutricia), and had their ulcers cleaned with warm saline solution and biguanide polyhexanide solution (Prontosan; B. Braun). Topical therapy in the first phase was papain 2% or 4% for group A and 2% hydrogel for group B. Both groups received single-layer elastic compression therapy (SurePress; ConvaTec). In the second phase, group A received compression therapy with Unna boot (Viscopaste; Smith-Nephew) as the primary dressing, while group B received a cellulose membrane (Membracel; Vuelo Pharma) followed by the Unna boot (Viscopaste; Smith-Nephew).In group A, 71.42% of the ulcers healed; in group B, the figure was 64.28%. Wound area, PUSH scores, and the occurrence and intensity of pain decreased significantly and equivalently in groups A and B.Both bundles are effective in the treatment of venous leg ulcers and pain relief.