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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

Tracking Information
First Submitted Date  ICMJE May 3, 2017
First Posted Date  ICMJE May 8, 2017
Last Update Posted Date December 23, 2019
Actual Study Start Date  ICMJE October 19, 2017
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
Wound Complications [ Time Frame: 24 weeks postoperatively ]
number of patients with wound complications
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Hyperbaric Oxygen Therapy on Wound Healing Following Management of Soft Tissue Sarcoma With Neo-Adjuvant Radiation and Surgical Resection
Official Title  ICMJE Prospective, Randomized Evaluation of Hyperbaric Oxygen Therapy on Wound Healing Following Management of Soft Tissue Sarcoma With Neo-Adjuvant Radiation and Surgical Resection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sarcoma
  • Hyperbaric Oxygen Therapy
Intervention  ICMJE Drug: Hyperbaric oxygen
Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period
Study Arms  ICMJE
  • Experimental: Hyperbaric Oxygen Group
    Patients will receive Hyperbaric Oxygen treatments in the immediate postoperative period
    Intervention: Drug: Hyperbaric oxygen
  • No Intervention: Standard of Care Group
    Patients will not receive Hyperbaric Oxygen treatments in the immediate postoperative period
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2017)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Will Eward 9196135550 william.eward@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03144206
Other Study ID Numbers  ICMJE Pro00065596
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP