The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations

July 17, 2023 updated by: Hassan Abdellatif Hamed, Sohag University

Fingertip injuries are among the most common hand injuries regardless of age, as the fingertip is a prominent and frequently used part of the hand. However, no consensus yet exists regarding the ideal reconstruction of fingertip injuries with nail bed defects, and its reconstructive methods are limited.

Allen has classified fingertip amputations into four types. Type I injuries involve only the pulp of the finger. Type II includes pulp and nail loss. Type III has partial terminal phalanx loss and corresponding pulp and nail loss. Finally, type IV involves the lunule of the nail, pulp, nail, and partial loss of the terminal phalanx.

Fingertip amputations through the proximal half of the nail-bed are challenging as the remaining nail-bed has inadequate length for satisfactory nail growth. Replantation at this level gives a good functional and cosmetic results but is technically demanding, requires microsurgical skills and adequate facilities and is not always possible.When replantation is not possible, the use of a local advancement palmar flap preserves digital length and the remaining nail bed.

However, when the amputation is through the proximal third of the nail, this technique leaves very little nail bed and nail deformities are common.To avoid these deformities, complete ablation of the nail bed and germinal matrix with closure by a palmar advancement flap, or by shortening, are usually carried out. Unfortunately, these treatments often fail to satisfy the patient's desire to retain his or her nail.

When replantation is not feasible, the technique of advancing a palmar V-Y flap and applying the nail bed retrieved from the amputated part to the dorsum of the flap provides an alternative means of restoring nail bed length. So the technique of using composite bone and nail bed graft from the amputated part with a local or regional cutaneous flaps may be an option for treatment of fresh fingertip amputation to restore the shape and preserve the length of the fingertip especially in circumstances when microsurgical replantation is not feasible.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: SaMIA Ahmed, professor

Study Locations

      • Sohag, Egypt, Sohag
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any level of finger tip amputations through the nail bed and distal phalanx with preserved amputated part.

Exclusion Criteria:

  • Crushed part of amputated segment.
  • Patients with peripheral vascular disease.
  • Diabetic patient.
  • Pateint over 65 or under 5 years of age.
  • Patient refusal.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with Finger Tip Amputations
  1. The amputated finger tip is cleaned and a composite graft including the nail bed and bone of distal phalanx is taken from the amputated part.
  2. The bone of the amputated part is fixed to the remaining stump of the distal phalanx with an axial 21gauge needle or by a K-wire (0.8 mm).
  3. The nail bed graft is sutured with 6-0 vicryl to the remaining nail bed.
  4. A local or regional cutaneous flap is used to cover the volar aspect and tip of the distal phalanx bone e.g. V-Y advancement flap, thenar flap or cross finger flap .The flap should protrude beyond the tip, providing extra skin which is recontoured to a rounded tip.
  5. The nail plate is inserted in the nail fold to prevent the formation of synechiae between the nail fold and the injured nail bed.
  6. The finger is immobilized for two weeks in a below elbow dorsal slab.
  7. Patients are followed up for 3 months. Postoperative complications and their management will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fingertip length
Time Frame: 1 year
Fingertip length is estimated in Centimeters
1 year

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

July 10, 2023

Primary Completion (Estimated)

June 10, 2024

Study Completion (Estimated)

June 10, 2024

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med-23-07-02MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Finger Tip Amputations

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