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Clinical Trials/NCT04049721
NCT04049721
Withdrawn
Not Applicable

Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries

NYU Langone Health1 site in 1 countrySeptember 1, 2021
ConditionsCrush Injury

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Crush Injury
Sponsor
NYU Langone Health
Locations
1
Primary Endpoint
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to determine whether using hyperbaric oxygen (HBO) improves wound healing for patients who have a crush injury. The comparison of the prospective intervention group to the retrospective matched cohort aims to show that HBO can improve wound healing and decrease poor outcomes for patients with crush injuries. The information gained from this small study will serve as a basis for a follow-up prospective, randomized control trial to further delineate the role of HBO in a larger patient population.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
September 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Presenting to NYU Winthrop Hospital with a crush injury of the extremity, including appendages, up to 14 days post injury.
  • No contraindication to hyperbaric oxygen therapy.
  • Able and willing to sign informed consent.

Exclusion Criteria

  • Critically-ill patient requiring intubation or pressor support.
  • Crush injury isolated to the distal phalanx (Tuft fracture).
  • Absolute contraindication to hyperbaric oxygen therapy (untreated pneumothorax). Relative contraindications (uncontrolled congestive heart failure, uncontrolled seizure disorder, pulmonary disease, claustrophobia) will be assessed by the treating physician.
  • Unable or unwilling to sign informed consent.

Outcomes

Primary Outcomes

healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).

Time Frame: week 52

Secondary Outcomes

  • hospital length of stay(52 Weeks)

Study Sites (1)

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