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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 : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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
Sarcoma Hyperbaric Oxygen Therapy Drug: Hyperbaric oxygen Phase 4

Study Design
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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

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Wound Complications [ Time Frame: 24 weeks postoperatively ]
    number of patients with wound complications


Secondary Outcome Measures :
  1. Surgical site infections or periprosthetic infections [ Time Frame: 24 weeks postoperatively ]
    number of patients with Surgical site infections or periprosthetic infections

  2. 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)

  3. Reoperation due to wound complications [ Time Frame: 24 weeks postoperatively ]
    Number of patients requiring reoperation due to wound complications


Eligibility Criteria
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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
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Will Eward 9196135550 william.eward@duke.edu

Locations
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United States, North Carolina
DUke University Recruiting
Durham, North Carolina, United States, 27710
Contact: William Eward         
Sponsors and Collaborators
Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03144206    
Other Study ID Numbers: Pro00065596
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019

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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:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms