NCT04049721WithdrawnNot Applicable
Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- 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).
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Study Sites (1)
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