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Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries

Primary Purpose

Crush Injury

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HBO
Standard of Care
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crush Injury

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care without HBO

HBO + Standard of Care

Arm Description

Intravenous access and fluid resuscitation (standard of care treatment)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

hospital length of stay
Number of days admitted over 52 weeks

Full Information

First Posted
July 30, 2019
Last Updated
June 14, 2022
Sponsor
NYU Langone Health
Collaborators
Winthrop University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04049721
Brief Title
Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries
Official Title
Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of manpower; logistic issues regarding the move of the in-hospital hyperbaric oxygen (HBO) chamber to an off-site location.
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Winthrop University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crush Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care without HBO
Arm Type
Active Comparator
Arm Description
Intravenous access and fluid resuscitation (standard of care treatment)
Arm Title
HBO + Standard of Care
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
HBO
Intervention Description
2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
Time Frame
week 2
Title
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
Time Frame
week 6
Title
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
Time Frame
week 24
Title
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
Time Frame
week 52
Secondary Outcome Measure Information:
Title
hospital length of stay
Description
Number of days admitted over 52 weeks
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrizio Petrone, MD
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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
IPD Sharing Access Criteria
The investigator who proposed to use the data.

Learn more about this trial

Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries

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