Healing Pressure Ulcers with Collagen or Hydrocolloid

A Randomized, Controlled Trial

Graumlich, James F. MD, FACP
Blough, Linda S. RN, BSN, CWOCN
McLaughlin, Richard G. MD
Milbrandt, Joseph C. PhD
Calderon, Cesar L. PhD
Agha, Syed Abbas MD
Scheibel, L. William MD, ScD, FACP

^*Department of Biomedical and Therapeutic Sciences, University of Illinois College of Medicine, Peoria, Illinois
^†Department of Medicine, University of Illinois College of Medicine, Peoria, Illinois
^‡Glaxo, Smith, Kline, Inc., Philadelphia, Pennsylvania
^§Clinical Investigation, OSF Saint Francis Medical Center, Peoria, Illinois.

Address correspondence to James F. Graumlich, MD, Department of Biomedical and Therapeutic Sciences, University of Illinois College of Medicine, One Illini Drive, Peoria, IL 61605. E-mail: [email protected]

BioCore Medical Technologies, Topeka, Kansas, donated the collagen product used in the trial. A grant from the Retirement Research Foundation, Chicago, Illinois, paid for other study supplies and paid partial salary support for the investigators.

Data were presented at the American College of Physicians—American Society of Internal Medicine, Illinois Associates meeting in Peoria, Illinois, May 23, 2001.

Journal of the American Geriatrics Society 51(2):p 147-154, February 2003.

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 mm²/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.