Non-inferiority randomised controlled trial of two contact layer dressings for the treatment of acute wounds (SLALOM).

Abstract

Objective: Pain induced by dressing removal is an important clinical problem in the management of acute wounds. Contact layer dressings are intended to protect the wound and minimise pain. This study was designed to compare two dressings of this type in terms of pain induced at the first dressing removal.

Method: Patients with acute wounds were randomly assigned to treatment with either an investigational product (n=78) or a comparator (n=81), and received treatment until their wound healed, or for a maximum period of 23 days.

Results: By the first dressing change (day 3±2), minimal pain (<30mm on a 100mm visual analogue scale) was observed by 97.4% of patients in the intervention group and 97.5% of patients in the control group (modified intention-to-treat population (mITT)). For both mITT and per protocol populations, the lower bound of the unilateral 97.5% confidence interval did not exceed the prespecified -10.0% non-inferiority margin; thus, the non-inferiority of the investigational product to comparator was confirmed. In total, 64.8% of patients achieved wound healing by day 21±2. Time to wound closure, estimated for 50% of the patients using the Kaplan-Meier model, was 20±1.9 days for the intervention group and 19±2.7 days for the control group. The re-epithelialisation area doubled from baseline to day 21±2 in both groups. The opposite trend was observed for granulation, fibrin and necrosis areas. The number of periwound skin abnormalities significantly decreased in both groups. A good safety profile was demonstrated.

Conclusion: The results of this study showed that the investigational product supported healing and was non-inferior to the comparator in minimising dressing-associated pain in acute wounds.