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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Recruitment Status : Withdrawn (lack of enrollment)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

Tracking Information
First Submitted Date May 8, 2019
First Posted Date May 30, 2019
Last Update Posted Date May 29, 2020
Actual Study Start Date December 24, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2019)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings
Official Title A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Finger Injuries
  • Amputation, Traumatic
Intervention
  • Other: Bacitracin
    For the first 30 people, bacitracin will be applied and covered with xeroform and gauze.
  • 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.
Study Groups/Cohorts
  • Biological Dressings
    Bacitracin will be applied and covered with xeroform and gauze
    Intervention: Other: Bacitracin
  • Artificial Dressings
    the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft
    Intervention: Other: Skin Graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: May 27, 2020)
0
Original Estimated Enrollment
 (submitted: May 28, 2019)
60
Estimated Study Completion Date May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03968835
Other Study ID Numbers 18-00132
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party NYU Langone Health
Study Sponsor NYU Langone Health
Collaborators Not Provided
Investigators
Principal Investigator: Jacques Hacquebord New York Langone Medical Center
PRS Account NYU Langone Health
Verification Date May 2020