A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings

NCT ID: NCT03968835

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-24

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Finger Injuries Amputation, Traumatic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Biological Dressings

Bacitracin will be applied and covered with xeroform and gauze

Bacitracin

Intervention Type OTHER

For the first 30 people, bacitracin will be applied and covered with xeroform and gauze.

Artificial Dressings

the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft

Skin Graft

Intervention Type OTHER

For the next 30 patients, the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft.

Interventions

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Bacitracin

For the first 30 people, bacitracin will be applied and covered with xeroform and gauze.

Intervention Type OTHER

Skin Graft

For the next 30 patients, the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* replantation candidate, incomplete distal finger-tip amputation
Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques Hacquebord

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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18-00132

Identifier Type: -

Identifier Source: org_study_id

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