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Clinical Trials/NCT04960332
NCT04960332RecruitingNot Applicable

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, Denmark2 sites in 1 country160 target enrollmentStarted: July 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
160
Locations
2
Primary Endpoint
Wound complication/healing

Study Overview

Brief Summary

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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

Standard treatment

No Intervention

Group A: Standard wound closure with staples and conventional wound dressing.

Prevena

Experimental

Group B: Wound closure with staples and Negative Pressure Wound Therapy (PREVENA PLUS™ Incision Management System).

Intervention: Prevena (Device)

Outcomes

Primary Outcomes

Wound complication/healing

Time Frame: 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.

Secondary Outcomes

  • Secondary outcome measures, primary wound healing.(1 year postoperatively)
  • Secondary outcome measures, MSTS.(1 year postoperatively)
  • Secondary outcome measures, TESS.(1 year postoperatively)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrea Thorn

PhD student and Medical Doctor, department of orthopedic surgery

Rigshospitalet, Denmark

Study Sites (2)

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