Objectives: High-quality randomised controlled trials (RCT) to support the use of Fibrin Sealants (FS) in neck dissection (ND) are lacking. The DEFeND trial assessed critical pilot/feasibility questions and signals from clinical outcomes to inform a future definitive trial. Patients and Methods: The study design piloted was a blinded surgical RCT. All participants underwent unilateral ND for head and neck cancer. Interventional arm: ND with application of FS. Control arm: ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administrative processes. Clinical outcomes included surgical complications (primary outcome), drainage volume, time to drain removal, length of hospital stay, pain and the Neck Dissection Impairment Index. Results: Recruitment completed ahead of time. Fifty-three patients were recruited, and 48 were randomised at a rate of 5.3 patients/month. Blinding of patients, research nurses and outcome assessors was effective. Two protocol deviations occurred. Two patients were lost to follow-up. The mean (SD) Comprehensive Complication Index in the interventional arm was 6.5 (12.8), and it was 9.9 (14.2) in the control arm. The median (IQR) time to drain removal (days) was shorter in the interventional arm (2.67 (2.42, 3.58) vs. 3.40 (2.50, 4.27)). However, this did not translate to a clinically significant reduction in median (IQR) length of hospital stay in days (intervention: 3.48 (2.64, 4.54), control: 3.74 (3.11, 4.62)). Conclusion: The proposed trial design was effective, and a definitive surgical trial is feasible. Whilst there was a tendency for FS to improve clinical outcomes, the effect size did not reach clinical or statistical significance. (ISRCTN99181100).
目的：目前缺乏高质量随机对照试验（RCT）支持纤维蛋白密封剂（FS）在颈淋巴结清扫术（ND）中的应用。DEFeND试验评估了关键性预试验/可行性问题及临床结局信号，为未来确定性试验提供依据。患者与方法：本研究采用盲法外科随机对照试验设计。所有参与者均因头颈癌接受单侧颈淋巴结清扫术。干预组：颈清扫联合纤维蛋白密封剂应用；对照组：单纯颈清扫术。可行性结局指标包括招募情况、盲法有效性、方案依从性及管理流程评估。临床结局指标包括手术并发症（主要结局）、引流量、引流管拔除时间、住院时长、疼痛程度及颈清扫功能障碍指数。结果：招募工作提前完成。共纳入53例患者，以每月5.3例的速度完成48例随机分组。患者、研究护士及结局评估者的盲法设置有效。发生2例方案偏离，2例患者失访。干预组综合并发症指数平均值为6.5（标准差12.8），对照组为9.9（标准差14.2）。干预组引流管拔除时间中位数（四分位距）更短（2.67天[2.42, 3.58] vs 3.40天[2.50, 4.27]），但住院时长中位数（四分位距）未呈现临床意义的缩短（干预组：3.48天[2.64, 4.54]，对照组：3.74天[3.11, 4.62]）。结论：本研究设计方案有效，开展确定性外科试验具有可行性。虽然纤维蛋白密封剂呈现改善临床结局的趋势，但效应量未达到临床或统计学显著性。（ISRCTN99181100）
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