Pilot feasibility randomized clinical trial of negative-pressure wound therapy versus usual care in patients with surgical wounds healing by secondary intention

被引：5

作者：

Arundel, C. ^{[1
]}

Fairhurst, C. ^{[1
]}

Corbacho-Martin, B. ^{[1
]}

Buckley, H. ^{[1
]}

Clarke, E. ^{[3
]}

Cullum, N. ^{[7
,8
]}

Dixon, S. ^{[4
]}

Dumville, J. ^{[7
]}

Firth, A. ^{[3
]}

Hendetson, E. ^{[5
]}

Lamb, K. ^{[9
]}

McGinnis, E. ^{[10
]}

Oswald, A. ^{[3
]}

Goncalves, P. Saramago ^{[2
]}

Soares, M. O. ^{[2
]}

Stubbs, N. ^{[9
]}

Chetter, I ^{[2
,6
]}

机构：

[1] Univ York, Dept Hlth Sci, York Trials Unit, York YO10 5DD, N Yorkshire, England

[2] Univ York, Ctr Hlth Econ, York, N Yorkshire, England

[3] Hull & East Yorkshire Hosp NHS Trust, Acad Vasc Surg Unit, Kingston Upon Hull, N Humberside, England

[4] Patient & Publ Involvement Grp, Kingston Upon Hull, N Humberside, England

[5] Hull & East Yorkshire Hosp NHS Trust, Outpatient Serv, Kingston Upon Hull, N Humberside, England

[6] Hull York Med Sch, Res Off, Kingston Upon Hull, N Humberside, England

[7] Univ Manchester, Fac Biol Med & Hlth, Sch Hlth Sci, Div Nursing Midwifery & Social Work, Manchester, Lancs, England

[8] Cent Manchester Univ Hosp NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, Res & Innovat Div, Manchester, Lancs, England

[9] Leeds Community Healthcare NHS Trust, Leeds Wound Res Unit, Leeds, W Yorkshire, England

[10] Leeds Teaching Hosp NHS Trust, Dept Tissue Viabil, Leeds, W Yorkshire, England

来源：

BJS OPEN | 2018年 / 2卷 / 03期

基金：

美国国家卫生研究院;

关键词：

D O I：

10.1002/bjs5.49

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

Background: Surgical wounds healing by secondary intention (SWHSI) are increasingly being treated with negative-pressure wound therapy (NPWT) despite a lack of high-quality research evidence regarding its clinical and cost-effectiveness. This pilot feasibility RCT aimed to assess the methods for and feasibility of conducting a future definitive RCT of NPWT for the treatment of SWHSI. Methods: Eligible consenting adult patients receiving care at the study sites (2 acute and 1 community) and with a SWHSI appropriate for NPWT or wound dressing treatment were randomized 1:1 centrally to receive NPWT or usual care (no NPWI). Participants were followed up every 1-2 weeks for 3 months. Feasibility (recruitment rate, time to intervention delivery) and clinical (time to wound healing) outcomes were assessed. Results: A total of 248 participants were screened for eligibility; 40 (16.1 per cent) were randomized, 19 to NPWT and 21 to usual care. Twenty-four of the 40 wounds were located on the foot. Participants received NPWT for a median of 18 (range 0-72) days. Two participants in the NPWT group never received the intervention and 14 received NPWT within 48 h of randomization. Five participants in the usual care group received NPWT during the study. Ten of the 40 wounds were deemed to have healed during the study. Conclusion: A full-scale RCT to investigate the clinical and cost-effectiveness of NPWT for SWHSI is feasible. This study identified crucial information on recruitment rates and data collection methods to consider during the design of a definitive RCT.

引用

页码：99 / 111

页数：13

共 17 条

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