Multicenter randomized controlled trial comparing the effectiveness and safety of hydrocellular and hydrocolloid dressings for treatment of category II pressure ulcers in patients at primary and long-term care institutions

Abstract

Background: Pressure ulcers are a major burden to patients because they affect health, well-being, and health-related quality of life. Thus, prevention and early treatment of pressure ulcers is a major challenge for health care professionals. Objective: To compare the efficacy of hydrocellular and hydrocolloid dressings after 8 weeks of treatment of category II pressure ulcers. Design: A prospective multicenter clinical trial with blinded outcome assessors. Participants and settings: Adult patients with category II pressure ulcers from primary and long-term care institutions on Majorca island. Methods: Category II ulcers were treated with ALLEVYN Adhesive ® dressings or VARIHESIVE ® GEL CONTROL dressings, with the primary outcome being healing of the ulcers in 8 weeks. Blinded confirmation of ulcer healing was performed by a treatment-group assessment committee. Estimates of cumulative survival probabilities were determined using the Kaplan-Meier method and analyses of effectiveness were performed using the chi-squared test. Results: A total of 169 patients with pressure ulcers were enrolled, 84 of whom received hydrocellular dressings and 85 of whom received hydrocolloid dressings. A total of 58% were women and 56% were from primary care institutions. The hydrocellular dressing group had a higher percentage of healed pressure ulcers at 8 weeks (90.7% vs. 77.1%, p = 0.039)and a shorter average healing time (3 weeks vs. 4 weeks, p = 0.015). Analysis of safety outcomes at 8 weeks indicated that the hydrocellular dressing group had a smaller proportion of ulcers that were unhealed (3.9% vs. 7.1%)and a smaller proportion of ulcers that progressed to a higher category or infection (5.3% vs. 15.7%), although these differences were not statistically significant. Conclusions: This study of patients with category II pressure ulcers indicated that hydrocellular dressings were superior to hydrocolloid dressings in terms of healing at 8 weeks and time required for healing, although these two dressings had similar safety profiles.