Randomised controlled trial evaluating the efficacy of wrap therapy for wound healing acceleration in patients with NPUAP stage II and III pressure ulcer
- Seiji Bito1,
- Akihiro Mizuhara2,
- Sandai Oonishi3,
- Kensuke Takeuchi2,
- Masatsune Suzuki4,
- Kazuhiro Akiyama5,
- Kazuyo Kobayashi6,
- Kayoko Matsunaga7
- 1Division of Clinical Epidemiology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan
- 2Sanwa Medical Corporation Higashi-Washinomiya Hospital, Saitama, Japan
- 3Nursing Health Services Facilities for the Elderly Hatta, Aichi, Japan
- 4Department of General Internal Medicine, Tsukuba Medical Center Hospital, Tsukuba, Japan
- 5Tokatsu Clinic Hospital, Matsudo-shi, Japan
- 6Wakaba Ostomy Center, Tokyo, Japan
- 7Department of Dermatology, Fujita Health University School of Medicine, Toyoake, Japan
- Correspondence to Dr Seiji Bito;
- Received 1 September 2011
- Accepted 12 December 2011
- Published 5 January 2012
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
To cite: Bito S, Mizuhara A, Onishi S, et al. Randomised controlled trial evaluating the efficacy of wrap therapy for wound healing acceleration in patients with NPUAP stage II and III pressure ulcer. BMJ Open 2012;2:e000371. doi:10.1136/bmjopen-2011-000371
Funding This study was supported by Division of the Health for the Elderly at Japanese Ministry of Health, Labour and Welfare. Grant name ‘Examination and Research Work into New Pressure Ulcer Treatments for the Care of the Elderly’. Funding agency did not interfere with any process of study content. All researchers are independent of the founder. No funding was received from any specific commercial company.
Competing interests None.
Ethical approval The Japanese Academy of Family Medicine Ethics Review Board examined and approved our research plan and informed consent process in October 2009.
Contributors SB conducted literature review, developed the initial protocol, examined statistical analysis and drafted the manuscript. AM wrote grant application, recruited collaboration facilities, developed the intervention protocol and planned research meeting and start-up meeting. SO contributed to research design, reviewed and amended the research protocol including intervention protocol and contributed to enrolment of patients. KT also contributed to research design, reviewed and amended the research protocol and contributed to enrolment of patients. MS contributed to basic concept of research design, reviewed and amended the research protocol. KA contributed to enrolment of patients and acquisition of data. KK contributed to research design and enrolment of patients. KM managed an outcome evaluation centre. All authors meet International Committee of Medical Journal Editors authorship criteria for inclusion.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data available.
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