Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries

Not Applicable

Withdrawn

• Conditions: Crush Injury
• Interventions: Other: Standard of Care; Procedure: HBO

• Registration Number: NCT04049721
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Study Start: 2021-09-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-21
• Primary Completion: 2022-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care without HBO	Standard of Care	Intravenous access and fluid resuscitation (standard of care treatment)
HBO + Standard of Care	HBO	Ten daily treatment sessions of HBO at 2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks
HBO + Standard of Care	Standard of Care	Ten daily treatment sessions of HBO at 2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks

Primary Outcome Measures

Name	Time	Method
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).	week 52

Secondary Outcome Measures

Name	Time	Method
hospital length of stay	52 Weeks	Number of days admitted over 52 weeks

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States