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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 85
Updated:10/20/2018
Start Date:October 19, 2017
End Date:December 2022
Contact:Will Eward
Email:william.eward@duke.edu
Phone:9196135550

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

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.


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)
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Durham, North Carolina 27710
(919) 684-8111
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