Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04049721

Enrollment

Registered

2019-08-08

Start date

2021-09-01

Completion date

2023-09-30

Last updated

2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crush Injury

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.

Interventions

PROCEDUREHBO

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

OTHERStandard 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame	Description
hospital length of stay	52 Weeks	Number of days admitted over 52 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026