Evaluation of heparin gel's effects on stage II pressure ulcers: a randomized controlled trial.

OBJECTIVES: Pressure ulcers are common in critically ill patients and can delay recovery. Heparin improves blood flow and reduces inflammation, which may help wound healing. This study compared an optimized heparin hydrogel with a standard hydrocolloid dressing for treating Stage II pressure ulcers in critically ill patients. METHODS: Eighteen heparin hydrogel formulations were prepared; eight met key physicochemical and stability criteria, and one optimized 1% formulation based on release profile, stability, and microbiological safety was selected for clinical testing. Patients were randomly assigned to receive either the heparin hydrogel or a hydrocolloid dressing every 3 days alongside standard wound care. Wound length, width, and surface area, as well as the Pressure Ulcer Scale for Healing (PUSH) score at baseline and on days 3, 7, and 14 after enrollment. RESULTS: Eighty-four patients were enrolled in the study, and 56 completed the trial (26 in the heparin hydrogel group and 30 in the hydrocolloid control group). The two groups were similar in baseline demographic and clinical characteristics. Both groups improved wound healing over time, but patients who received the heparin hydrogel had greater reductions in PUSH scores, wound length, width, and surface area by day 14 (p < 0.05). The median healing time was 7 days (95% CI 5.8-8.2) in the heparin group and 10 days (95% CI 8.8-11.2) in the hydrocolloid group (p < 0.001). No local or systemic adverse events were reported during the study. CONCLUSIONS: Heparin hydrogel treatment was well-tolerated and effectively accelerated wound recovery in patients with stage II pressure ulcers. Nonetheless, further research is warranted to elucidate the role of heparin hydrogel in pressure ulcer management.