Evaluation of Hyperbaric Oxygen Therapy on Wound Healing Following Management of Soft Tissue Sarcoma With Neo-Adjuvant Radiation and Surgical Resection

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, randomized investigation with appropriate power would determine whether or not postoperative hyperbaric oxygen therapy improves wound healing in patients with soft tissue sarcoma undergoing surgical resection with neo-adjuvant radiation therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University

Criteria

Inclusion Criteria:

1. Males and females within the ages of 18-85

2. Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist

3. Sarcoma of lower extremity location

4. Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection

5. Expected primary wound closure performed at the time at surgery

6. Any disease stage

7. Any tumor grade

8. Any histologic subtype

9. First or recurrent presentations

10. No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity

11. No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied

12. Must be able to comply with follow up visits

13. Must be able to provide own consent

Exclusion Criteria:

1. Patients under the age of 18, or over the age of 85.

2. Treatment plan that doesn't include neo-adjuvant radiation and surgical excision

3. Sarcoma location other than lower extremity

4. History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied

5. High dose steroid therapy (defined as >5mg prednisone, or equivalent, daily)

6. Active treatment with chemotherapy

7. Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)

8. Plan for post operative radiation therapy

9. Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity

10. Vascular disease resulting in clinically apparent compromise in blood flow to the treatment extremity (i.e. peripheral vascular disease with diminished pulses, venous insufficiency with clinical evidence of vascular congestion)

11. Actively uncontrolled diabetes mellitus (documentation of history of DM with A1c>8)

12. Active deep vein thrombosis in the treatment extremity

13. Inability to comply with follow up visits

14. Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)