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

NCT02638298 | Completed Results DMC

• 1 other identifier: Pro00028423
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Cancer; Infectious Disease

Outcome Measures

Primary Outcomes (1)

• Wound Complication Rate

  To estimate the wound complication rate of post-operative negative pressure dressings and traditional dry dressings, and risk of secondary interventions after resection of soft tissue sarcoma in lower extremities that have received pre-operative radiation. Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).

  longitudinally up to 6 months postoperatively

Study Arms (2)

NPWT dressing

EXPERIMENTAL

Device: Prevana Dressing

Standard dry gauze dressing

PLACEBO COMPARATOR

Other: Standard Dry Gauze Dressing

Interventions

Prevana Dressing DEVICE

negative pressure wound therapy (NPWT) dressing

NPWT dressing

Standard Dry Gauze Dressing OTHER

Standard Dry Gauze Dressing

Standard dry gauze dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• 3M: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Sarcoma; Neoplasms; Communicable Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Leddy
• Organization: Medical University of South Carolina

leddyl@musc.edu

843-876-1119

Study Officials

• Lee R Leddy, MD

  Medical University of South Carolins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 23, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)