Randomised controlled trial evaluating the efficacy of wrap therapy for wound healing acceleration in patients with NPUAP stage II and III pressure ulcer

OBJECTIVES: To evaluate if ‘wrap therapy’ using food wraps, which is widely used in Japanese clinical sites, is not inferior when compared to guideline adhesion treatments. DESIGN: Multicentre, prospective, randomised, open, blinded endpoint clinical trial. SETTING: 15 hospitals in Japan. PATIENTS: 66 older patients with new National Pressure Ulcer Advisory Panel stage II or III pressure ulcers. INTERVENTIONS: Of these 66 patients, 31 were divided into the conventional treatment guidelines group and 35 into the wrap therapy group. MAIN OUTCOME MEASURES: The primary end point was the period until the pressure ulcers were cured. The secondary end point was a comparison of the speed of change in the Pressure Ulcer Scale for Healing score. RESULTS: 64 of the 66 patients were analysed. The estimated mean period until healing was 57.5 days (95% CI 45.2 to 69.8) in the control group as opposed to 59.8 days (95% CI 49.7 to 69.9) in the wrap therapy group. By the extent of pressure ulcer infiltration, the mean period until healing was 16.0 days (95% CI 8.1 to 23.9) in the control group as opposed to 18.8 days (95% CI 10.3 to 27.2) in the wrap therapy group with National Pressure Ulcer Advisory Panel stage II ulcers, and 71.8 days (95% CI 61.4 to 82.3) as opposed to 63.2 days (95% CI 53.0 to 73.4), respectively, with stage III ulcers. There is no statistical significance in difference in Pressure Ulcer Scale for Healing scores. CONCLUSIONS: It might be possible to consider wrap therapy as an alternative choice in primary care settings as a simple and inexpensive dressing care. CLINICAL TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000002658. Summary protocol is available on https://upload.umin.ac.jp/cgi-bin/ctr/ctr.cgi?function=brows&action=brows&type=detail&recptno=R000003235&admin=0&language=J