Oxford Trauma and Emergency Care, Kadoorie Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Br J Surg. 2023 Nov 9;110(12):1774-1784. doi: 10.1093/bjs/znad298.
Hand trauma, comprising injuries to both the hand and wrist, affects over five million people per year in the NHS, resulting in 250 000 operations each year. Surgical site infection (SSI) following hand trauma surgery leads to significant morbidity. Triclosan-coated sutures may reduce SSI in major abdominal surgery but have never been tested in hand trauma. Feasibility needs to be ascertained before a definitive trial can be delivered in hand trauma.
A multicentre feasibility RCT of antimicrobial sutures versus standard sutures involving adults undergoing surgery for hand trauma to evaluate feasibility for a definitive trial. Secondary objectives were incidence of SSI in both groups, hand function measured with patient-reported outcome measures, health-related quality of life and change in employment. Randomization was performed on a 1:1 basis, stratified by age of the patient and whether the injury was open or closed, using a secure, centralized, online randomization service. Participants were blinded to allocation.
116 participants were recruited and randomized (60 intervention, 56 control). Of 227 screened, most were eligible (89.5 per cent), and most who were approached agreed to be included in the study (84.7 per cent). Retention was low: 57.5 per cent at 30 days, 52 per cent at 90 days and 45.1 per cent at 6 months. Incidence of SSI was >20 per cent in both groups. Hand function deteriorated after injury but recovered to near pre-injury levels during the study period.
Risk of SSI after hand trauma is high. A definitive RCT of antimicrobial sutures in hand trauma surgery is feasible, if retention is improved.
ISRCTN10771059.
手部创伤包括手部和腕部损伤，每年在英国国家医疗服务体系（NHS）中影响超过 500 万人，每年有 25 万例手术。手部创伤手术后的手术部位感染（SSI）会导致严重的发病率。三氯生涂层缝线可减少重大腹部手术中的 SSI，但从未在手创伤中进行过测试。在手部创伤中进行确定性试验之前，需要确定其可行性。
一项涉及成年人手部创伤手术的抗菌缝线与标准缝线的多中心可行性 RCT，以评估确定性试验的可行性。次要目标是两组 SSI 的发生率、患者报告的手部功能测量结果、健康相关生活质量和就业变化。采用安全、集中、在线随机化服务，按患者年龄和损伤是开放性还是闭合性进行分层，以 1:1 的比例进行随机分组。参与者对分组情况不知情。
共招募和随机分配了 116 名参与者（60 名干预组，56 名对照组）。在 227 名筛查者中，大多数符合条件（89.5%），大多数被邀请的人都同意参加研究（84.7%）。保留率低：30 天时为 57.5%，90 天时为 52%，6 个月时为 45.1%。两组的 SSI 发生率均>20%。手部功能在受伤后恶化，但在研究期间恢复到接近受伤前的水平。
手部创伤后 SSI 的风险很高。如果提高保留率，抗菌缝线在手创伤手术中的确定性 RCT 是可行的。
ISRCTN8273347。
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