Faurschou Ida Kaad, Sørensen Marlene Julia, Pedersen Allan Gorm, Rasmussen Simon Ladefoged, Erichsen Rune, Haas Susanne
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Pilonidal Disease Center, Department of Surgery, Randers Regional Hospital, Randers, Denmark.
Colorectal Dis. 2024 Oct 6;27(1). doi: 10.1111/codi.17198.
Despite favourable outcomes in recurrence after off-midline closure techniques in pilonidal surgery, between 18% and 40% of patients suffer from prolonged postoperative wound healing. The aim of this work was to investigate if closed-incision negative-pressure wound therapy (NPWT) promotes wound healing after Bascom's cleft lift (BCL) surgery for complicated pilonidal sinus disease compared with conventional drainage and dressing.
Patients were randomized to either NPWT for 4-7 days or loop-vessel drain for 24 h and a dry dressing postoperatively. Healing was evaluated by a wound care nurse blinded for randomization at 2 and 12 weeks postoperatively (primary endpoint). Healing was defined as one or no closing defects of ≤5 mm and with no undermining.
Although we had wanted to recruit 200 patients, the study was terminated at 118 patients (NPWT group, n = 60; control group, n = 58) after interim analysis. Patients were comparable by age, sex, body mass index, previous smoking status and indication for BCL surgery. At 2 weeks 12% of patients were healed in both the NPWT and control groups [risk difference = 0.00(95% CI -0.12 to 0.11), p = 1.00]. After 12 weeks, 68% of patients were healed in the NPWT group and 72% in the control group [risk difference = -0.03 (95% CI 0.19 to 0.13), p = 0.82]. There was no significant difference in pain experienced postsurgery. In a symptom-based questionnaire, the control group reported self-esteem to be less affected (p = 0.015).
Closed-incision negative-pressure wound therapy did not significantly improve healing after BCL surgery for complicated pilonidal sinus disease.
尽管在藏毛窦手术中采用偏离中线闭合技术后复发率有良好结果，但仍有18%至40%的患者术后伤口愈合时间延长。本研究的目的是调查与传统引流和换药相比，闭合切口负压伤口治疗（NPWT）是否能促进复杂藏毛窦疾病的巴斯康氏裂隙提升术（BCL）术后伤口愈合。
患者被随机分为接受4 - 7天的NPWT治疗组或术后接受24小时环形血管引流及干敷料治疗组。由对随机分组不知情的伤口护理护士在术后2周和12周评估愈合情况（主要终点）。愈合定义为存在一个或不存在≤5毫米的闭合缺损且无潜行。
尽管我们原计划招募200名患者，但在中期分析后，该研究在118名患者（NPWT组，n = 60；对照组，n = 58）时终止。患者在年龄、性别、体重指数、既往吸烟状况和BCL手术指征方面具有可比性。在2周时，NPWT组和对照组均有12%的患者愈合[风险差异 = 0.00（95%可信区间 -0.12至0.11），p = 1.00]。12周后，NPWT组68%的患者愈合，对照组72%的患者愈合[风险差异 = -0.03（95%可信区间 -0.19至0.13），p = 0.82]。术后疼痛程度无显著差异。在一份基于症状的问卷中，对照组报告自尊受影响较小（p = 0.015）。
对于复杂藏毛窦疾病的BCL手术，闭合切口负压伤口治疗并未显著改善术后愈合情况。
