Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds

NCT ID: NCT02638298

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2024-07-31

Brief Summary

This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound.

The investigators will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.

Detailed Description

Postoperative surgical site infections pose a significant challenge to the orthopaedic oncologist, especially in wounds that have been previously irradiated with neo adjuvant external beam radiation therapy (EBRT). There are many studies demonstrating the relatively high risk of wound complications after lower extremity sarcoma resection. Published data suggest that these preoperatively radiated wounds have a postoperative infection rate of 17%-44% with "traditional" dressings (e.g. dry gauze surgical dressings).

A prospective series of 190 patients and showed a wound complication risk of 35% in preoperative irradiated wounds. The morbidity associated with wound complications can range from moderate (prolonged dressing changes) to severe (life or limb threatening infection). Patients who develop wound complications have been shown to longer hospitalizations and higher costs [ref]. Anatomic location of the tumor has been shown to be a risk factor for the development of wound complications with lower extremities being higher risk than upper extremities. There are several published studies examining the effect of negative pressure wound therapy (NPWT) on high risk surgical wounds. Abdominal wound complications can be reduced with the use of incisional NPWT. In the orthopaedic literature the use of negative pressure incisional dressings have been shown to lower the risk of wound complications in total hip arthroplasty, acetabular fractures, and extremity fractures.

To our knowledge, there have not been any published studies on the utility of negative pressure wound therapy in previously irradiated soft tissue sarcoma wounds. The investigators feel that this high risk patient cohort could potentially benefit from reducing wound complications through NPWT and is an ideal population to study its effect.

Conditions

Sarcoma; Cancer; Infectious Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NPWT dressing

Group Type: EXPERIMENTAL

Prevana Dressing

Intervention Type: DEVICE

negative pressure wound therapy (NPWT) dressing

Standard dry gauze dressing

Group Type: PLACEBO_COMPARATOR

Standard Dry Gauze Dressing

Intervention Type: OTHER

Standard Dry Gauze Dressing

Interventions

Prevana Dressing

negative pressure wound therapy (NPWT) dressing

Intervention Type: DEVICE

Standard Dry Gauze Dressing

Standard Dry Gauze Dressing

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age>18
• Willing to consent to randomization and able to participate in the study
• Lower extremity soft tissue sarcoma necessitating radiation prior to surgical resection
• Primary closure of wound
• Patients scheduled for surgical resection

Exclusion Criteria

• Flap coverage or skin graft
• Patients scheduled for amputations as local control of their tumor
• Sarcomas where radiation is not planned preoperatively
• Repeat surgeries for oncologic reasons (positive margins)
• Known allergy to adhesive tape

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee R Leddy, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolins

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00028423

Identifier Type: -

Identifier Source: org_study_id