Crush InjuryNCT04049721
Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries
A study testing HBO in people with Crush Injury, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Crush Injury
- What is being tested?
- HBO
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- HBO, Standard of Care
- Medical subject headings
- Crush Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOProcedure or surgery
2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks.
Standard of CareOther
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 group | Role | What they receive |
|---|---|---|
| Standard of Care without HBO | Active comparator | Intravenous access and fluid resuscitation (standard of care treatment) Receives: 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 Receives: Procedure: HBO; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: week 52
Secondary outcomes (1)
hospital length of stay
Number of days admitted over 52 weeks
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Sep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Lack of manpower; logistic issues regarding the move of the in-hospital hyperbaric oxygen (HBO) chamber to an off-site location.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crush InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Winthrop University Hospital
- Responsible party
- Sponsor
- Investigators
- Patrizio Petrone, MD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049721
- Sponsor's protocol ID
- s19-01074
- Status last verified
- Jun 2022
- First submitted
- 30 Jul 2019
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries
- ClinicalTrials.gov ID
- NCT04049721
- Acronym / sponsor ID
- s19-01074
- Conditions
- Crush Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of manpower; logistic issues regarding the move of the in-hospital hyperbaric oxygen (HBO) chamber to an off-site location.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Winthrop University Hospital
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care without HBO | Active comparator | Other: Standard of CareIntravenous access and fluid resuscitation (standard of care treatment) |
| HBO + Standard of Care | Experimental | Procedure: HBO, Other: Standard of CareTen 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBO2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks. | Procedure or surgery | HBO + Standard of Care |
| Standard of Care20 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. | Other | HBO + Standard of Care, Standard of Care without HBO |
Primary outcome
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
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
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
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
1 secondary outcome
hospital length of stay
Time frame: 52 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrizio Petrone, MD principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBO in people with Crush Injury, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.