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

NCT03968835 | Withdrawn

• 1 other identifier: 18-00132
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Finger Injuries; Amputation, Traumatic

Outcome Measures

Primary Outcomes (5)

• Time to complete healing up to 3 Months

  3 months

• Percentage of graft viability (for biological dressing only)

  1 week

• Percentage of graft viability (for biological dressing only)

  3 weeks

• Percentage of graft viability (for biological dressing only)

  6 weeks

• Percentage of graft viability (for biological dressing only)

  3 months

Study Arms (2)

Biological Dressings

Bacitracin will be applied and covered with xeroform and gauze

Other: Bacitracin

Artificial Dressings

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

Other: Skin Graft

Interventions

Bacitracin OTHER

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

Biological Dressings

Skin Graft 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.

Artificial Dressings

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• replantation candidate, incomplete distal finger-tip amputation

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Finger Injuries; Amputation, Traumatic

Interventions

Bacitracin; Skin Transplantation

Condition Hierarchy (Ancestors)

Hand Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Jacques Hacquebord

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 30, 2019
• Study Start: December 24, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

US (1)