Arundel C, Fairhurst C, Corbacho-Martin B, Buckley H, Clarke E, Cullum N, Dixon S, Dumville J, Firth A, Henderson E, Lamb K, McGinnis E, Oswald A, Saramago Goncalves P, Soares M O, Stubbs N, Chetter I
York Trials Unit, Department of Health Sciences University of York York UK.
Academic Vascular Surgical Unit Hull and East Yorkshire Hospitals NHS Trust Hull UK.
BJS Open. 2018 Apr 23;2(3):99-111. doi: 10.1002/bjs5.49. eCollection 2018 Jun.
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.
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 NPWT). 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.
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.
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. Registration number: ISRCTN12761776 (http://www.iscrtn.com).
尽管缺乏关于负压伤口治疗（NPWT）临床和成本效益的高质量研究证据，但二期愈合的手术伤口（SWHSI）越来越多地采用负压伤口治疗。这项试点可行性随机对照试验旨在评估未来进行NPWT治疗SWHSI的确定性随机对照试验的方法和可行性。
在研究地点（2个急性护理点和1个社区护理点）接受护理且有适合NPWT或伤口敷料治疗的SWHSI的符合条件并同意参与的成年患者，以1∶1的比例集中随机分组，接受NPWT或常规护理（不进行NPWT）。参与者每1 - 2周随访一次，共随访3个月。评估可行性（招募率、开始干预的时间）和临床（伤口愈合时间）结局。
共筛选了248名参与者以确定其是否符合条件；40名（16.1%）被随机分组，19名接受NPWT，21名接受常规护理。40个伤口中有24个位于足部。参与者接受NPWT的中位时间为18天（范围0 - 72天）。NPWT组有2名参与者从未接受干预，14名在随机分组后48小时内接受了NPWT。常规护理组有5名参与者在研究期间接受了NPWT。40个伤口中有10个在研究期间被认为已愈合。
开展一项全面的随机对照试验以研究NPWT治疗SWHSI的临床和成本效益是可行的。本研究确定了在设计确定性随机对照试验时需考虑的关于招募率和数据收集方法的关键信息。注册号：ISRCTN12761776（http://www.iscrtn.com）。
