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临床试验/NCT04960332
NCT04960332招募中不适用

Effect of Negative Pressure Wound Therapy After Surgical Removal of Deep-Seated High-Malignant Soft Tissue Sarcomas of the Extremities and Trunk Wall. A Randomized Controlled Trial

Rigshospitalet, Denmark3 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
3
主要终点
Wound complication/healing

研究概览

简要总结

The purpose of this research project is to improve the surgical treatment of Soft Tissue Sarcoma (STS) treatment based upon a Randomized Controlled Trial (RCT). We want to evaluate the effect of the use of Negative Pressure Wound Therapy (NPWT) versus a conventional wound dressing on postoperative wound complications after surgical removal of deep-seated high-malignant STS of the extremities or trunk wall.

详细描述

Introduction

Sarcomas are a heterogeneous group of rare malignant tumors of mesenchymal cell origin in the musculoskeletal system comprising 1% of all adult cancers. The reported incidence of all types of sarcomas is approximately six to eight per 100,000 inhabitants corresponding to 300 cases per year in Denmark (250 STS (100 retroperitoneal/abdominal STS), 50 bone sarcomas). Sarcomas arise in the body's connective tissues including bone, muscle, cartilage, fat tissue, blood vessels, and peripheral nerve-sheaths and hence arise in all parts of the body although most dominant in the extremities (78%).

There exist more than 50 histologic subtypes of STS yielding a broad heterogeneous morphology and biological behavior of all subtypes. The incidence of STS is in general increasing with age (median age=65). High-grade soft tissue sarcomas mostly metastasize hematogenous to the lungs, which is also the primary cause of sarcoma-specific death and approximately 10% of patients with STS have metastases at diagnosis.

Treatment of STS requires a multidisciplinary highly specialized team, evaluating risks and benefits of all available options and expected outcomes with the aim to minimize the recurrence of disease and preserve function and quality of life. The main treatment principles that have largely been unchanged since the 1980ies is surgery supplemented with adjuvant radiotherapy depending on subtype and stage. The use of NPWT after high-risk orthopedic surgeries such as e.g. amputations, treatment of open fractures and joint replacement surgery are increasing, but the direct cost is much higher compared to the conventional wound dressing. However, previous studies have shown that NPWT can reduce postoperative complications such as wound dehiscence and infection. STS surgery that is often combined with pre-or postoperative radiation therapy is a high-risk procedure concerning wound complications and postoperative infections. A retrospective study showed that NPWT reduced the risk of wound complications in patients with lower extremity STS treated with preoperative radiation and the use of NPWT was not associated with an increased risk of local recurrence.

Methods

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Surgery for a deep-seated STS of an extremity or the trunk wall at Rigshospitalet.

排除标准

  • Age < 18 years
  • Wound closure not possible without plastic surgery (pedicled or free flaps)
  • Low malignant (Trojani grade 1) STS or borderline tumors
  • Pre- or postoperative chemotherapy
  • Preoperative radiotherapy to the local site.
  • Allergic or hypersensitive to acrylic adhesives or silver
  • Unwilling or unable to provide informed consent
  • Inability to comply with planned study procedures
  • Patients with metastatic disease.
  • Patients with ischemic surgery such as bypass or endovascular prosthesis

结局指标

主要结局

Wound complication/healing

时间窗: 120 days postoperatively

A major wound complication defined as in O'Sullivan et al. \[11\]: * A secondary surgery under anesthesia for wound repairs such as debridement, operative drainage and secondary wound closure. * Wound management without secondary surgery, this includes invasive procedure without anesthesia such as aspiration of seroma and readmission for wound care such as intravenous antibiotic or persistent deep packing within 4 months (120 days) after surgery.

次要结局

  • Secondary outcome measures, seroma.(1 year postoperatively)
  • Secondary outcome measures, readmission.(1 year postoperatively)
  • Secondary outcome measures, hospital stay.(1 year postoperatively)
  • Secondary outcome measures, deep infection.(1 year postoperatively)
  • Secondary outcome measures, 5Q-5D.(1 year postoperatively)
  • Secondary outcome measures, primary wound healing.(1 year postoperatively)
  • Secondary outcome measures, MSTS.(1 year postoperatively)
  • Secondary outcome measures, TESS.(1 year postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Thorn

PhD student and Medical Doctor, department of orthopedic surgery

Rigshospitalet, Denmark

研究点 (3)

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