N/A
N=160
Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds
Sarcoma · Cancer · Infectious Disease
Bottom Line
View on ClinicalTrials.gov: NCT02638298 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Wound Complication Rate — 3.7; 3.7; 2.1; 2.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prevana Dressing (Device); Standard Dry Gauze Dressing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Complication Rate |
3.7; 3.7; 2.1; 2.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02638298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.