Evaluation of Hyperbaric Oxygen Therapy on Wound Healing Following Management of Soft Tissue Sarcoma With Neo-Adjuvant Radiation and Surgical Resection
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ClinicalTrials.gov Identifier: NCT03144206 |
Recruitment Status :
Recruiting
First Posted : May 8, 2017
Last Update Posted : January 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma Hyperbaric Oxygen Therapy | Drug: Hyperbaric oxygen | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective, Randomized Evaluation of Hyperbaric Oxygen Therapy on Wound Healing Following Management of Soft Tissue Sarcoma With Neo-Adjuvant Radiation and Surgical Resection |
Actual Study Start Date : | October 19, 2017 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Hyperbaric Oxygen Group
Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period
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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
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- Wound Complications [ Time Frame: 24 weeks postoperatively ]number of patients with wound complications
- Surgical site infections or periprosthetic infections [ Time Frame: 24 weeks postoperatively ]number of patients with Surgical site infections or periprosthetic infections
- Local wound management [ Time Frame: 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 [ Time Frame: 24 weeks postoperatively ]Number of patients requiring reoperation due to wound complications

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients under the age of 18, or over the age of 85.
- Treatment plan that doesn't include neo-adjuvant radiation and surgical excision
- Sarcoma location other than lower extremity
- History of radiation therapy to the tumor and/or surgical area prior to the current treatment being studied
- High dose steroid therapy (defined as >5mg prednisone, or equivalent, daily)
- Active treatment with chemotherapy
- Inability of the patient to provide informed consent (i.e. dementia, cognitive impairment, non-English speakers)
- Plan for post operative radiation therapy
- Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
- 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)
- Actively uncontrolled diabetes mellitus (documentation of history of DM with A1c>8)
- Active deep vein thrombosis in the treatment extremity
- Inability to comply with follow up visits
- Pregnant females (women of childbearing potential must have a negative serum pregnancy test prior to enrollment)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144206
Contact: Will Eward | 9196135550 | william.eward@duke.edu |
United States, North Carolina | |
DUke University | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: William Eward |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT03144206 |
Other Study ID Numbers: |
Pro00065596 |
First Posted: | May 8, 2017 Key Record Dates |
Last Update Posted: | January 12, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |