Finger InjuriesNCT03968835
A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings
An observational study of Finger Injuries and Amputation, Traumatic, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a prospective study looking to evaluate whether the treatment outcomes for patients who sustain a distal fingertip amputation are improved or no different when using biological dressings versus artificial dressings. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Finger Injuries, Amputation, Traumatic
- What is being tested?
- Bacitracin and Skin Graft
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Dec 2018to May 2021
- Phase
- Observational
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 60 patients will be followed for the study. The first 30 patients will be treated with biological dressings and subsequent 30 patients will be treated with artificial dressings.
Who may be able to join
- All individuals presenting at Bellevue Hospital for evaluation and treatment of a finger amputation distal to the germinal matrix that present along with the amputated distal fingertip unit.
Who cannot join
- replantation candidate, incomplete distal finger-tip amputation
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This is a prospective study looking to evaluate whether the treatment outcomes for patients who sustain a distal fingertip amputation are improved or no different when using biological dressings versus artificial dressings.
- Conditions
- Finger Injuries, Amputation, Traumatic
- Being tested
- Bacitracin, Skin Graft
- Medical subject headings
- Finger Injuries, Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BacitracinOther
For the first 30 people, bacitracin will be applied and covered with xeroform and gauze.
Skin GraftOther
For the next 30 patients, the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft.
| Study group | Role | What they receive |
|---|---|---|
| Biological Dressings | Bacitracin will be applied and covered with xeroform and gauze Receives: Other: Bacitracin | |
| Artificial Dressings | the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft Receives: Other: Skin Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete healing up to 3 Months
Measured: 3 months
Percentage of graft viability (for biological dressing only)
Measured: 1 week
Percentage of graft viability (for biological dressing only)
Measured: 3 weeks
Percentage of graft viability (for biological dressing only)
Measured: 6 weeks
Percentage of graft viability (for biological dressing only)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start24 Dec 2018
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Finger InjuriesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Hacquebord, Principal investigator, New York Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968835
- Sponsor's protocol ID
- 18-00132
- Status last verified
- May 2020
- First submitted
- 8 May 2019
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings
- ClinicalTrials.gov ID
- NCT03968835
- Acronym / sponsor ID
- 18-00132
- Conditions
- Finger Injuries, Amputation, Traumatic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 30 May 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.
This is a prospective study looking to evaluate whether the treatment outcomes for patients who sustain a distal fingertip amputation are improved or no different when using biological dressings versus artificial dressings.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological Dressings | – | Other: BacitracinBacitracin will be applied and covered with xeroform and gauze |
| Artificial Dressings | – | Other: Skin Graftthe amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 60 patients will be followed for the study. The first 30 patients will be treated with biological dressings and subsequent 30 patients will be treated with artificial dressings.
Key inclusion criteria (1 listed)
- All individuals presenting at Bellevue Hospital for evaluation and treatment of a finger amputation distal to the germinal matrix that present along with the amputated distal fingertip unit.
Key exclusion criteria (1 listed)
- replantation candidate, incomplete distal finger-tip amputation
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 |
|---|---|---|
| BacitracinFor the first 30 people, bacitracin will be applied and covered with xeroform and gauze. | Other | Biological Dressings |
| Skin GraftFor the next 30 patients, the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft. | Other | Artificial Dressings |
Primary outcome
Time to complete healing up to 3 Months
Time frame: 3 months
Percentage of graft viability (for biological dressing only)
Time frame: 1 week
Percentage of graft viability (for biological dressing only)
Time frame: 3 weeks
Percentage of graft viability (for biological dressing only)
Time frame: 6 weeks
Percentage of graft viability (for biological dressing only)
Time frame: 3 months
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 29 May 2020.
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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.
Jacques Hacquebord principal investigator
New York Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Finger Injuries and Amputation, Traumatic, 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 1 inclusion and 1 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 29 May 2020. 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?
Time to complete healing up to 3 Months (time frame: 3 months). The study lists 5 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 29 May 2020.