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

May 27, 2020 updated by: NYU Langone Health
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biological Dressings
Bacitracin will be applied and covered with xeroform and gauze
Other: Bacitracin
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to complete healing up to 3 Months
Time Frame: 3 months
3 months
Percentage of graft viability (for biological dressing only)
Time Frame: 1 week
1 week
Percentage of graft viability (for biological dressing only)
Time Frame: 3 weeks
3 weeks
Percentage of graft viability (for biological dressing only)
Time Frame: 6 weeks
6 weeks
Percentage of graft viability (for biological dressing only)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Jacques Hacquebord, New York Langone Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2018

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 28, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-00132

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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