Finger Tip AmputationsNCT05961891
The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations
A study testing The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations in people with Finger Tip Amputations, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Finger Tip Amputations
- What is being tested?
- The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2023to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any level of finger tip amputations through the nail bed and distal phalanx with preserved amputated part.
Who cannot join
- Crushed part of amputated segment.
- Patients with peripheral vascular disease.
- Diabetic patient.
- Pateint over 65 or under 5 years of age.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
SaMIA Ahmed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor
About this study
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.
Read more
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.
- Conditions
- Finger Tip Amputations
- Being tested
- The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip AmputationsProcedure or surgery
- 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.
- 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).
- The nail bed graft is sutured with 6-0 vicryl to the remaining nail bed.
- 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.
- The nail plate is inserted in the nail fold to prevent the formation of synechiae between the nail fold and the injured nail bed.
- The finger is immobilized for two weeks in a below elbow dorsal slab.
- Patients are followed up for 3 months. Postoperative complications and their management will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Finger Tip Amputations | Experimental | Patients with Finger Tip Amputations Receives: Procedure: The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fingertip length
Fingertip length is estimated in Centimeters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start10 Jul 2023
- Primary completion10 Jun 2024 (estimated)
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Finger Tip AmputationsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Abdellatif Hamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961891
- Sponsor's protocol ID
- Soh-Med-23-07-02MS
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 7002744Brown 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.
PubMed 10194021Celik 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.
PubMed 12045538Cheung K, Hatchell A, Thoma A. Approach to traumatic hand injuries for primary care physicians. Can Fam Physician. 2013 Jun;59(6):614-8.
PubMed 23766041
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations
- ClinicalTrials.gov ID
- NCT05961891
- Acronym / sponsor ID
- Soh-Med-23-07-02MS
- Conditions
- Finger Tip Amputations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Finger Tip Amputations | Experimental | Procedure: The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip AmputationsPatients with Finger Tip Amputations |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any level of finger tip amputations through the nail bed and distal phalanx with preserved amputated part.
Key exclusion criteria (5 listed)
- Crushed part of amputated segment.
- Patients with peripheral vascular disease.
- Diabetic patient.
- Pateint over 65 or under 5 years of age.
- Patient refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations1. 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. | Procedure or surgery | Patients with Finger Tip Amputations |
Primary outcome
Fingertip length
Time frame: 1 year
Fingertip length is estimated in Centimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 7002744Allen MJ. Conservative management of finger tip injuries in adults. Hand. 1980 Oct;12(3):257-65. doi: 10.1016/s0072-968x(80)80049-0.
- Background: PubMed 10194021Brown 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.
- Background: PubMed 12045538Celik 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.
- Background: PubMed 23766041Cheung K, Hatchell A, Thoma A. Approach to traumatic hand injuries for primary care physicians. Can Fam Physician. 2013 Jun;59(6):614-8.
- Individual participant dataSharing planned: Undecided
Related trials for Finger Tip Amputations
Recruiting
Non-Contact Low-Frequency Ultrasound Vs Standard LaLonde Protocol for Fingertip Injury Wound Healing
Non-contact Low Frequency Ultrasound, Lalonde Protocol
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SaMIA Ahmed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Use of Composite Bone and Nail Bed Graft Combined With Cutaneous Flaps for Reconstruction of Finger Tip Amputations in people with Finger Tip Amputations, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan H Hamed, resident (01158742230, hassanhamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fingertip length (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05961891, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.