Department of Radiology, Jena University Hospital, Friedrich Schiller University of Jena; Institute for Medical Statistics, Computer Science and Data Science Jena, Jena University Hospital, Jena; Department of General, Visceral and Vascular Surgery, Jena University Hospital, Friedrich-Schiller-University Jena; Department of Trauma-, Handand Reconstructive Surgery, University Hospital Jena, Friedrich-Schiller-University Jena; Department of Dermatology, University Hospital Jena, Friedrich-Schiller-University Jena.
Dtsch Arztebl Int. 2021 Nov 5;118(44):749-755. doi: 10.3238/arztebl.m2021.0324.
Wound healing after pectoral port implantation is a major factor determining the success or failure of the procedure. Infection and wound dehiscence can endanger the functionality of the port system and impede chemotherapy. The cosmetic result is important for patient satisfaction as well.
From August 2015 to July 2017, adult patients with an indication for port implantation were entered into a prospective, randomized and controlled single-center study. The skin incision was closed either with tissue adhesive or with an intracutaneous suture. The primary endpoints were the total score of the scar evaluated by the patient and the investigator on the POSAS scale (Patient and Observer Scar Assessment Scale: 6 [normal skin] to 60 points), blinded assessment of photographic documentation by ten evaluating physicians, and the patient's reported quality of life. The calculation of case numbers was based only on the patients' overall POSAS assessment, which was tested for non-inferiority. The secondary endpoints were other complications (infection, dehiscence) and the duration of wound closure (trial registration number NCT02551510).
156 patients (60 ± 13 years, 64% women) participated in the study. The patient-assessed total POSAS score of tissue adhesive revealed non-inferiority to suturing (adhesive 11.7 ± 5.8 vs. suture 10.1 ± 4.0, p for non-inferiority <0.001). Both the investigators in their POSAS assessments and the blinded physician evaluators in their assessment of photographically documented wounds rated wound closure by suturing better than closure with tissue adhesive. No significant differences were found between groups with respect to quality of life or the frequency of wound infection or dehiscence.
Closure of the upper cutaneous layer with tissue adhesive is a suitable and safe method of wound closure after port implantation.
胸壁端口植入后的伤口愈合是决定手术成败的主要因素。感染和伤口裂开会危及端口系统的功能，并阻碍化疗。美容效果对患者满意度也很重要。
从 2015 年 8 月至 2017 年 7 月，有植入端口适应证的成年患者被纳入一项前瞻性、随机对照的单中心研究。皮瓣切口采用组织胶或皮内缝合关闭。主要终点是患者和研究者根据 POSAS 量表（患者和观察者瘢痕评估量表：6[正常皮肤]至 60 分）评估的瘢痕总评分、由 10 名评估医生进行的照片记录盲法评估以及患者报告的生活质量。病例数的计算仅基于患者整体 POSAS 评估，该评估用于测试非劣效性。次要终点为其他并发症（感染、裂开）和伤口闭合时间（试验注册号 NCT02551510）。
156 名患者（60±13 岁，64%为女性）参与了研究。组织胶的患者评估总 POSAS 评分显示非劣效于缝合（胶 11.7±5.8 与缝 10.1±4.0，p 非劣效性<0.001）。在 POSAS 评估中，调查员和对照片记录伤口进行盲法评估的医生都认为缝合的伤口闭合优于组织胶。两组在生活质量或伤口感染或裂开的频率方面无显著差异。
在上皮层采用组织胶闭合是植入端口后伤口闭合的一种合适且安全的方法。
