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Lack of manpower; logistic issues regarding the move of the in-hospital hyperbaric oxygen (HBO) chamber to an off-site location.
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| Name | Class |
|---|---|
| Winthrop University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care without HBO | Active Comparator | Intravenous access and fluid resuscitation (standard of care treatment) |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBO | Procedure | 2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks. |
|
| Measure | Description | 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| hospital length of stay | Number of days admitted over 52 weeks | 52 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrizio Petrone, MD | New York Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
The investigator who proposed to use the data.
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| ID | Term |
|---|---|
| D000071576 | Crush Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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. |
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