Department of Orthopedic Surgery, University Hospital of Copenhagen, Rigshospitalet, Inge Lehmanns Vej 6, 2100, Copenhagen, Denmark.
Trials. 2022 Jun 18;23(1):507. doi: 10.1186/s13063-022-06468-6.
Sarcomas are a heterogeneous group of rare malignant tumors of mesenchymal origin in the musculoskeletal system. The main treatment is surgery often supplemented with pre-or postoperative radiotherapy. A retrospective study by Bedi et al. indicated that negative pressure wound therapy (NPWT) reduced the risk of postoperative wound complications in patients treated with preoperative radiation followed by surgical tumor removal of lower extremity soft tissue sarcomas (STS), and the use of NPWT was not associated with an increased risk of local recurrence. Previous studies have shown that NPWT can reduce postoperative complications. STS surgeries are a high-risk procedure concerning wound complications.
Non-blinded single-center randomized controlled trial comparing NPWT versus conventional wound dressing and postoperative wound complications after surgical removal of deep-seated high-malignant STS of the extremities or trunk wall Sample-size calculation: 154 STS patients (80% risk of avoiding type II error, 5% risk of type I error, and an 80% wound complication risk) Block randomization of 8 into: Group A: Conventional wound dressing Group B: NPWT (PREVENA PLUS™ Incision Management System) Inclusion criteria: Surgery for a deep-seated STS of an extremity or the trunk wall Exclusion criteria: Age < 18 years, plastic surgery, low malignant/borderline STS, chemotherapy, preoperative radiotherapy, allergic/hypersensitive to acrylic adhesives or silver, unwilling/unable to provide informed consent, metastatic disease, and ischemic surgeries Primary study endpoints were set as major wound complications defined by O'Sullivan et al. as a secondary surgery under anesthesia for wound repairs and wound management without secondary surgery within 4 months postoperatively. Secondary study endpoints among others are Musculoskeletal Tumor Society Score (MSTS), Toronto Extremity Salvage Score (TESS), and European Quality of Life - 5 Dimensions (EQ-5D). Approval from the Scientific Ethical Committee and the Data Protection Agency has been obtained, and the study is registered at clinicaltrial.gov . This study did not apply for external funding.
Many new medical devices and technical solutions are currently being introduced, and even though some documentation regarding the use of NPWT, e.g., in joint replacement surgery exist, it is also important to seek documentation for this treatment principle in STS surgery.
Registered at ClinicalTrials.gov NCT04960332 and approved on 11 July 2021.
肉瘤是一种起源于间叶组织的罕见恶性肿瘤，主要发生于肌肉骨骼系统。主要治疗方法是手术，通常辅以术前或术后放疗。Bedi 等人的回顾性研究表明，负压伤口治疗（NPWT）降低了接受术前放疗后行下肢软组织肉瘤（STS）手术切除的患者术后伤口并发症的风险，且 NPWT 的使用与局部复发风险增加无关。既往研究表明，NPWT 可降低术后并发症。STS 手术是一种与伤口并发症相关的高风险手术。
非盲单中心随机对照试验，比较 NPWT 与传统伤口敷料在下肢或躯干壁深部高危 STS 手术后的术后伤口并发症。样本量计算：154 例 STS 患者（80%规避 II 类错误风险，5% I 类错误风险，80%伤口并发症风险）将 8 例患者按 8 例分组：A 组：传统伤口敷料；B 组：NPWT（PREVENA PLUS™ 切口管理系统）纳入标准：手术治疗肢体或躯干壁深部 STS；排除标准：年龄<18 岁，整形手术，低度恶性/交界性 STS，化疗，术前放疗，对丙烯酸胶粘剂或银过敏/敏感，不同意/无法提供知情同意，转移性疾病，缺血性手术。主要研究终点设定为 O'Sullivan 等人定义的主要伤口并发症，即术后 4 个月内需要再次麻醉行伤口修复和伤口管理的二次手术。次要研究终点包括肌肉骨骼肿瘤学会评分（MSTS）、多伦多肢体挽救评分（TESS）和欧洲生活质量-5 维度（EQ-5D）。已获得科学伦理委员会和数据保护局的批准，并在 clinicaltrial.gov 注册。本研究未申请外部资金。
目前正在引入许多新的医疗器械和技术解决方案，尽管已经有一些关于 NPWT 使用的文件，例如在关节置换手术中的使用，但在 STS 手术中也需要寻找关于这种治疗原则的文件。
ClinicalTrials.gov 注册，NCT04960332，2021 年 7 月 11 日批准。
