Aneurin Bevan University Health Board, Royal Gwent Hospital, Newport, UK.
Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, West Yorkshire, UK.
Clin Exp Dermatol. 2022 Oct;47(10):1829-1838. doi: 10.1111/ced.15273. Epub 2022 Jul 24.
There is no agreed treatment pathway following excision of keratinocyte cancer (KC). Compression therapy is considered beneficial for secondary intention healing on the lower leg; however, there is a lack of supportive evidence. To plan a randomized controlled trial (RCT), suitable data are needed. We report a multicentre prospective observational cohort study in this patient population with the intention of informing a future trial design.
To estimate the time to healing in wounds healing by secondary intention without planned postoperative compression, following excision of KC on the lower leg; to characterize the patient population, including factors affecting healing; and to assess the incidence of complications.
This was a multicentre prospective observational cohort study. Inclusion criteria were age ≥ 18 years with planned excision of KC on the lower leg and healing by secondary intention, an ankle-brachial pressure index (ABPI) of ≥ 0.8; and written informed consent. Exclusion criteria included planned excision with primary closure, skin graft or flap; compression therapy for another indication; planned compression; inability of patient to receive, comply with or tolerate high compression; or a suspected diagnosis other than KC.
This study recruited 58 patients from 9 secondary care dermatology clinics. In the analysis population (n = 53), mean age was 81 years (range 25-97 years), median time to healing was 81 days (95% CI 73-92) and 45 patients (84.9%) had healing of the wound at the 6-month follow-up. The healing prognostic factors were wound parameters and ABPI. Wound infections occurred in 16 participants (30.2%). Four patients (7.5%) were admitted to hospital; three because of an infection and one because of a fall.
The collected data have informed the RCT preparation. A relatively high proportion (7.5-15%) of unhealed wounds, infection and hospital admissions demonstrate the need for clearly establishing potentially effective treatments to improve outcomes for this population.
切除角化细胞癌 (KC) 后，尚无公认的治疗途径。压迫疗法被认为有益于小腿二期愈合；然而，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。我们报告了一项多中心前瞻性观察队列研究，旨在为未来的试验设计提供信息。
估计在小腿 KC 切除后不计划术后加压的情况下，二期愈合的伤口愈合时间；描述患者人群，包括影响愈合的因素；并评估并发症的发生率。
这是一项多中心前瞻性观察队列研究。纳入标准为年龄≥18 岁，计划切除小腿 KC，二期愈合，踝肱指数 (ABI)≥0.8；并签署书面知情同意书。排除标准包括计划切除后一期闭合、植皮或皮瓣；出于其他原因使用压迫疗法；计划使用压迫疗法；患者无法接受、遵守或耐受高压；或疑似诊断为 KC 以外的疾病。
本研究从 9 个二级皮肤科诊所招募了 58 名患者。在分析人群 (n=53) 中，平均年龄为 81 岁（范围 25-97 岁），中位愈合时间为 81 天（95%CI 73-92），45 名患者（84.9%）在 6 个月随访时伤口愈合。愈合的预测因素是伤口参数和 ABI。16 名参与者（30.2%）发生伤口感染。4 名患者（7.5%）住院；3 名因感染，1 名因跌倒。
收集的数据为 RCT 准备提供了信息。未愈合伤口、感染和住院的比例相对较高（7.5-15%），表明需要明确确定潜在有效的治疗方法，以改善该人群的结局。
