Managing sacral pressure ulcers with hydrocolloid dressings: results of a controlled, clinical study.

One-hundred and three patients with Stage II and III sacral pressure ulcers were enrolled in a prospective, controlled, multi-center clinical study to evaluate and compare dressing performance, safety and efficacy. Fifty-two patients were randomized to treatment with a triangle-shaped hydrocolloid border dressing and 51 patients were randomized to a different, oval shape, hydrocolloid dressing. The majority of patients (70 percent) utilized a pressure reducing mattress or bed. Most ulcers were Stage II, had existed for < 1 month and exhibited no change utilizing previous treatments. Patients and wounds were similarly distributed among treatment groups. Patients in the oval dressing group were more likely to exhibit a product related adverse reaction resulting in discontinuation of treatment as compared to patients treated with the triangle border dressing (p = 0.057, Fisher's Exact Test). Wear time was longest for wounds dressed with the triangle dressing applied point down. Incontinence reduced the interval between dressing changes in both groups. Healing was more likely to occur in wounds dressed with the triangle border dressing. These ulcers showed a greater reduction in ulcer width as compared to wounds dressed with the oval dressing (p < 0.03, Fisher's Exact Test).

RCT Entities:   Population Interventions Outcomes