Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Aneurin Bevan University Health Board, Royal Gwent Hospital, Newport, UK.
Clin Exp Dermatol. 2022 Oct;47(10):1839-1847. doi: 10.1111/ced.15283. Epub 2022 Jul 27.
Compression therapy is considered beneficial for postsurgical lower leg wound healing by secondary intention; however, there is a lack of supportive evidence. To plan a randomized controlled trial (RCT), suitable data are needed.
To determine the feasibility of recruitment and estimate recruitment rate; to understand the standard postoperative wound management pathway; to determine uptake of optional additional clinic visits for healing confirmation; and to explore patient acceptability of compression bandaging and plan a future RCT.
Participant recruitment was performed from secondary care dermatology clinics, during a period of 22 months. Inclusion criteria were age ≥ 18 years, planned excision of keratinocyte cancer on the lower leg with healing by secondary intention and an ankle-brachial pressure index of ≥ 0.8. Exclusion criteria were planned primary closure/graft or flap; inability to receive, comply with or tolerate high compression; planned compression; or suspected melanoma. Patients were followed up weekly (maximum 6 months) in secondary care clinics and/or by telephone. Information was collected on healthcare resource use, unplanned compression, wound healing and an optional clinic visit to confirm healing.
This study recruited 58 patients from 9 secondary care dermatology clinics over 22 months. Mean recruitment/centre/month was 0.8 (range 0.1-2.3). Four centres had dedicated Research Nurse support. The analysis population (n = 53) had weekly follow-up assessments. Standard care clinical contacts were: general practitioner (7 visits; 1.2%), community nurse (169; 28.5%), practice nurse visits (189; 31.8%) and dermatology clinic visits (138; 23.2%). Participants whose wounds healed (34 of 45; 75.6%) attended an optional clinic visit.
Data were obtained to inform a future RCT. Recruitment rates were found to be higher in centres with dedicated research support. People would be willing to take part in a trial and attend a confirmation of healing visit.
压缩疗法被认为有益于二期愈合的小腿术后伤口愈合，但缺乏支持性证据。为了计划一项随机对照试验（RCT），需要合适的数据。
确定招募的可行性并估计招募率；了解标准的术后伤口管理途径；确定是否接受可选的额外门诊就诊以确认愈合；并探索患者对压缩绷带的接受程度，为未来的 RCT 制定计划。
参与者招募在二级护理皮肤科诊所进行，为期 22 个月。纳入标准为年龄≥18 岁，计划切除小腿角质形成细胞癌，二期愈合，踝肱指数≥0.8。排除标准为计划一期闭合/移植或皮瓣；无法接受、遵守或耐受高压；计划使用压缩；或疑似黑色素瘤。患者在二级护理诊所和/或通过电话每周（最长 6 个月）接受随访。收集医疗资源使用、非计划压缩、伤口愈合和可选的门诊就诊以确认愈合的信息。
这项研究在 22 个月内从 9 家二级护理皮肤科诊所招募了 58 名患者。平均每月每个中心招募人数为 0.8 人（范围为 0.1-2.3）。4 家中心配备了专门的研究护士。分析人群（n=53）每周进行评估。标准护理临床联系包括：全科医生（7 次就诊；1.2%）、社区护士（169 次就诊；28.5%）、门诊护士就诊（189 次就诊；31.8%）和皮肤科诊所就诊（138 次就诊；23.2%）。45 例伤口愈合的患者（34 例；75.6%）参加了可选的门诊就诊。
获得了未来 RCT 的相关数据。有专门研究支持的中心招募率较高。人们愿意参加试验并接受愈合确认就诊。
