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NCT03968835 Clinical Trial

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

Amputation, Traumatic Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03968835
Other study ID # 18-00132
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 24, 2018
Est. completion date May 2021

Study information
Verified date May 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)
Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to complete healing up to 3 Months 3 months
Primary Percentage of graft viability (for biological dressing only) 1 week
Primary Percentage of graft viability (for biological dressing only) 3 weeks
Primary Percentage of graft viability (for biological dressing only) 6 weeks
Primary Percentage of graft viability (for biological dressing only) 3 months
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