Randomized Pilot Study Evaluating Hyperbaric Oxygen Therapy Following Management of Soft Tissue Sarcoma With Neo-adjuvant Radiation and Surgical Resection
A parallel-group randomized pilot trial at a single institution (Duke University) on the effect of postoperative hyperbaric oxygen therapy on wound healing in patients with soft tissue sarcoma undergoing surgical resection with neo-adjuvant radiation therapy.. Participants will be allocated to either the treatment group (HBOT) or control (standard of care) by computer-generated randomization, stratified by tumor size (≤10cm and \>10cm). An unequal randomization of 2:1 will be utilized to provide experience prescribing HBOT to more patients.
• Males and females within the ages of 18-85
• Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
• Sarcoma of lower extremity location
• Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
• Expected primary wound closure performed at the time at surgery
• Any disease stage
• Any tumor grade
• Any histologic subtype
• First or recurrent presentations
⁃ No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
⁃ No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
⁃ Must be able to comply with follow up visits
⁃ Must be able to provide own consent