Seiji Bito, Akihiro Mizuhara, Sandai Oonishi, Kensuke Takeuchi, Masatsune Suzuki, Kazuhiro Akiyama, Kazuyo Kobayashi, Kayoko Matsunaga
BMJ OPEN 2(1) 000371 2012年
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