Healing pressure ulcers with collagen or hydrocolloid: a randomized, controlled trial.

OBJECTIVES To compare the effects of topical collagen and hydrocolloid on pressure ulcer healing. DESIGN Randomized (allocation concealed), single-blind (outcome assessors), controlled trial with 8-week follow-up. SETTING Eleven nursing homes in central Illinois. PARTICIPANTS Sixty-five patient-residents with Stage II or III pressure ulcers: median age 83.1, median Braden score 12, 63% female, 80% Stage II ulcers, and 20% Stage III ulcers. Exclusion criteria included cellulitis and osteomyelitis. INTERVENTION Thirty-five patients were allocated to topical collagen daily, 30 to topical hydrocolloid twice weekly. MEASUREMENTS The primary outcome was complete healing within 8 weeks. Secondary outcomes were time to heal, ulcer area healed per day, linear healing of wound edge, and cost of therapy. RESULTS Analysis by intention to treat revealed similar complete ulcer healing within 8 weeks in collagen (51%) and hydrocolloid (50%) recipients (difference 1%, 95% confidence interval (CI) = 26-29%). Mean healing time was similar: collagen healed in 5 weeks (95% CI = 4-6), hydrocolloid healed in 6 weeks (95% CI = 5-7). Mean area healed per day was 6 mm(2)/d in both treatment groups. Mean linear healing of the wound edge was 3 mm in both groups. In multivariate analysis, baseline ulcer depth was the only independent predictor of complete ulcer healing within 8 weeks (odds ratio = 0.56, 95% CI = 0.38-0.81). Cost analysis favored hydrocolloid. CONCLUSIONS There were no significant differences in healing outcome between collagen and hydrocolloid. Collagen was more expensive and offered no major benefits to patients otherwise eligible for hydrocolloid treatment.