- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05961891
The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations
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
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hassan H Hamed, resident
- Phone Number: 01158742230
- Email: hassanhamed@med.sohag.edu.eg
Study Contact Backup
- Name: SaMIA Ahmed, professor
Study Locations
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-
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Sohag, Egypt, Sohag
- Recruiting
- Sohag University Hospital
-
Contact:
- Magdy M Amin, professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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Experimental: Patients with Finger Tip Amputations
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|
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
Sponsor
Publications and helpful links
General Publications
- Celik N, Wei FC, Lin CH, Cheng MH, Chen HC, Jeng SF, Kuo YR. Technique and strategy in anterolateral thigh perforator flap surgery, based on an analysis of 15 complete and partial failures in 439 cases. Plast Reconstr Surg. 2002 Jun;109(7):2211-6; discussion 2217-8. doi: 10.1097/00006534-200206000-00005.
- Allen MJ. Conservative management of finger tip injuries in adults. Hand. 1980 Oct;12(3):257-65. doi: 10.1016/s0072-968x(80)80049-0.
- Brown RE, Zook EG, Russell RC. Fingertip reconstruction with flaps and nail bed grafts. J Hand Surg Am. 1999 Mar;24(2):345-51. doi: 10.1053/jhsu.1999.0345.
- Cheung K, Hatchell A, Thoma A. Approach to traumatic hand injuries for primary care physicians. Can Fam Physician. 2013 Jun;59(6):614-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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