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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03968835
Recruitment Status : Withdrawn (lack of enrollment)
First Posted : May 30, 2019
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment
Finger Injuries Amputation, Traumatic Other: Bacitracin Other: Skin Graft

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings
Actual Study Start Date : December 24, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Time to complete healing up to 3 Months [ Time Frame: 3 months ]
  2. Percentage of graft viability (for biological dressing only) [ Time Frame: 1 week ]
  3. Percentage of graft viability (for biological dressing only) [ Time Frame: 3 weeks ]
  4. Percentage of graft viability (for biological dressing only) [ Time Frame: 6 weeks ]
  5. Percentage of graft viability (for biological dressing only) [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968835


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jacques Hacquebord New York Langone Medical Center
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03968835    
Other Study ID Numbers: 18-00132
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amputation, Traumatic
Finger Injuries
Wounds and Injuries
Hand Injuries
Bacitracin
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents