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

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03144206
Collaborator
(none)
20
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2
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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
  • Drug: Hyperbaric oxygen
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 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 :
Oct 19, 2017
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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

  1. Wound Complications [24 weeks postoperatively]

    number of patients with wound complications

Secondary Outcome Measures

  1. Surgical site infections or periprosthetic infections [24 weeks postoperatively]

    number of patients with Surgical site infections or periprosthetic infections

  2. 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)

  3. Reoperation due to wound complications [24 weeks postoperatively]

    Number of patients requiring reoperation due to wound complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

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.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03144206
Other Study ID Numbers:
  • Pro00065596
First Posted:
May 8, 2017
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022