This randomized pilot trial studies how well incisional negative pressure wound therapy after surgery works in preventing infection in patients with soft tissue sarcomas who have undergone external beam radiation therapy. Negative pressure wound therapy consists of a wound sponge attached to a gentle suction device and may work better than standard dry gauze dressing in preventing infection after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02638298.
PRIMARY OBJECTIVES:
I. 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 and the pelvis that have received pre-operative radiation.
II. To estimate the total cost of care and resource utilization in patients treated with negative pressure wound therapy and traditional dry dressings.
OUTLINE: Patients are randomized to 1 of 2 groups.
NEGATIVE PRESSURE WOUND THERAPY (NPWT) GROUP: Patients receive NPWT dressing after surgery until days 5 to 7 and then receive standard dry gauze dressing as needed.
CONTROL GROUP: Patients receive standard dry gauze dressing after surgery until day 2 and then daily for the next week or until the wound is dry.
After completion of study treatment, patients are followed up at 2 and 6 weeks and 3 and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMedical University of South Carolina
Principal InvestigatorLee Leddy
