Evaluation of Hyperbaric Oxygen Therapy on Wound Healing Following Management of Soft Tissue Sarcoma With Neo-Adjuvant Radiation and Surgical Resection
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Hyperbaric Oxygen Group Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period |
Drug: Hyperbaric oxygen
Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period
|
No Intervention: Standard of Care Group Patients will not receive Hyperbaric Oxygen treatments in the immediate postoperative period |
Outcome Measures
Primary Outcome Measures
- Wound Complications [24 weeks postoperatively]
number of patients with wound complications
Secondary Outcome Measures
- Surgical site infections or periprosthetic infections [24 weeks postoperatively]
number of patients with Surgical site infections or periprosthetic infections
- Local wound management [24 weeks postoperatively]
Number of patients requiring local wound management (such as wound packing, negative pressure therapy or other advanced dressings/wound care techniques)
- Reoperation due to wound complications [24 weeks postoperatively]
Number of patients requiring reoperation due to wound complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males and females within the ages of 18-85
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Diagnosis of soft tissue sarcoma that has been histologically confirmed by an approved reference pathologist
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Sarcoma of lower extremity location
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Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
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Expected primary wound closure performed at the time at surgery
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Any disease stage
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Any tumor grade
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Any histologic subtype
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First or recurrent presentations
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No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
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No history of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
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Must be able to comply with follow up visits
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Must be able to provide own consent
Exclusion Criteria:
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Patients under the age of 18, or over the age of 85.
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Treatment plan that doesn't include neo-adjuvant radiation and surgical excision
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Sarcoma location other than lower extremity
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History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
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High dose steroid therapy (defined as >5mg prednisone, or equivalent, daily)
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Active treatment with chemotherapy
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Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
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Plan for post operative radiation therapy
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Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
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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)
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Actively uncontrolled diabetes mellitus (documentation of history of DM with A1c>8)
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Active deep vein thrombosis in the treatment extremity
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Inability to comply with follow up visits
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Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | DUke University | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00065596