Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries

NYU Langone Health

Status: Withdrawn

Conditions: Crush Injury

Treatments: Procedure: HBO; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04049721

s19-01074

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Standard of Care without HBO

Active Comparator group

Description:

Intravenous access and fluid resuscitation (standard of care treatment)

Treatment:

Other: Standard of Care

HBO + Standard of Care

Experimental group

Description:

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

Treatment:

Procedure: HBO

Other: Standard of Care