This randomized clinical trial studies how well hyperbaric oxygen therapy works in improving wound healing in patients with soft tissue sarcoma undergoing radiation therapy and surgery. Hyperbaric oxygen therapy involves breathing pure oxygen in a pressurized room or tube. Giving hyperbaric oxygen therapy after radiation treatment and surgery may help improve wound healing in patients with soft tissue sarcoma.
Additional locations may be listed on ClinicalTrials.gov for NCT03144206.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: William Eward
Phone: 919-681-6982
PRIMARY OBJECTIVES:
I. To compare the overall wound complication rate (including wound dehiscence, tissue necrosis, seroma formation, need for wound packing/negative pressure therapy or other advanced wound care techniques, infection, need for re-operation due to wound complication-including irrigation and debridement and soft tissue coverage procedures) between patients with soft tissue sarcomas treated with hyperbaric oxygen therapy (HBOT) and not treated with HBOT following neo-adjuvant radiation therapy and surgical resection.
II. To compare the rate of delayed wound healing (wound dehiscence, tissue necrosis, seroma formation, need for wound packing/negative pressure therapy or other advanced wound care techniques) between patients with soft tissue sarcomas treated with HBOT and not treated with HBOT following neo-adjuvant radiation therapy and surgical resection.
III. To compare the rate of surgical site infections between patients with soft tissue sarcomas treated with HBOT and not treated with HBOT following neo-adjuvant radiation therapy and surgical resection.
IV. To compare the rate of reoperation due to wound complications (including irrigation and debridement, or soft tissue coverage techniques) between patients with soft tissue sarcomas treated with HBOT and not treated with HBOT following neo-adjuvant radiation therapy and surgical resection.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo standard of care radiation therapy and surgery. Beginning 1 day after surgery, patients undergo 10 treatments with HBOT over 2 hours with an average goal of twice daily (BID) treatments for 5-10 days.
GROUP II: Patients undergo standard of care radiation therapy and surgery.
After completion of study, patients are followed up at 3, 6, 12, and 24 weeks from the time of surgery.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorWilliam Eward