Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries

Crush Injury Clinical Trial

Official title:

Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04049721
• Other study ID #: s19-01074
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 2023

Study information

• Verified date: June 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crush Injuries
• Crush Injury
• Wounds and Injuries

Intervention

Procedure:
• HBO
2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks.

Other:
• Standard of Care
20 patients will be included in the retrospective review arm. The retrospective chart review will be performed to determine the outcomes of patients with crush injuries treated at NYU Winthrop Hospital without HBO from 1/1/2012-12/31/2018.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).		week 2
Primary	healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).		week 6
Primary	healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).		week 24
Primary	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	hospital length of stay	Number of days admitted over 52 weeks	52 Weeks