Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries

NCT04049721 | Withdrawn

• 1 other identifier: s19-01074
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Crush Injury

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• hospital length of stay

  52 Weeks

Study Arms (2)

Standard of Care without HBO

ACTIVE COMPARATOR

Intravenous access and fluid resuscitation (standard of care treatment)

Other: Standard of Care

HBO + Standard of Care

EXPERIMENTAL

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

Procedure: HBO; Other: Standard of Care

Interventions

HBO PROCEDURE

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 OTHER

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.

HBO + Standard of Care; Standard of Care without HBO

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Winthrop University Hospital: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Crush Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Patrizio Petrone, MD

  New York Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 8, 2019
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
• Access Criteria: The investigator who proposed to use the data.

Locations

US (1)