Nerve InjuryNCT01533337
Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits
A study testing Free dorsal digital flap in people with Nerve Injury and Digital Pulp Defect, run by The Second Hospital of Tangshan.
Trial summary
The aim of the current report is to investigate the feasibility of transferring the free dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to reconstruct the volar soft tissue defect of digits. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Nerve Injury, Digital Pulp Defect
- What is being tested?
- Free dorsal digital flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Oct 2011
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- soft tissue defects in the fingertip, pulp, or volar surface of the digits;
- a defect > 2 cm in length;
- unavailability of the homodigital and heterodigital island flaps because of concomitant injuries to donor fingers; and
- the patient refuses to use tissues from the toe.
Who cannot join
- soft tissue defects in the dorsum of the digits;
- a defect < 2 cm in length;
- homodigital and heterodigital island flaps are available.
About this study
The aim of the current report is to investigate the feasibility of transferring the free dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured.
Read the detailed description
Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured. The data were compared with those of the contralateral, uninjured hand.
- Conditions
- Nerve Injury, Digital Pulp Defect
- Being tested
- Free dorsal digital flap
- Keywords
- dorsal digital free flap, dorsal branch of proper digital nerve, dorsal branch of proper digital artery, proper digital artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free dorsal digital flapProcedure or surgery
The dorsal digital flap, including both dorsal branches of the proper digital nerves, was designed on the dorsum of the donor finger between the distal third of the proximal phalanx and the distal interphalangeal joint.
| Study group | Role | What they receive |
|---|---|---|
| finger | Other | Free dorsal digital flap transferring is used for reconstruction of soft-tissue defects Receives: Procedure: Free dorsal digital flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
static 2-point discrimination (2PD) test
The test points were at the centers of the radial and ulnar portions of the digital pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMay 2007
- Primary completionMay 2009
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve InjuryStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Tangshan
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533337
- Sponsor's protocol ID
- Tschen3886
- Status last verified
- Feb 2012
- First submitted
- 10 Feb 2012
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits
- ClinicalTrials.gov ID
- NCT01533337
- Acronym / sponsor ID
- Tschen3886
- Conditions
- Nerve Injury, Digital Pulp Defect
- Keywords
- dorsal digital free flap, dorsal branch of proper digital nerve, dorsal branch of proper digital artery, proper digital artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- May 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Feb 2012 (estimated)
- 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.
The aim of the current report is to investigate the feasibility of transferring the free dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured.
Detailed description
Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured. The data were compared with those of the contralateral, uninjured hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| finger | Other | Procedure: Free dorsal digital flapFree dorsal digital flap transferring is used for reconstruction of soft-tissue defects |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- soft tissue defects in the fingertip, pulp, or volar surface of the digits;
- a defect > 2 cm in length;
- unavailability of the homodigital and heterodigital island flaps because of concomitant injuries to donor fingers; and
- the patient refuses to use tissues from the toe.
Key exclusion criteria (3 listed)
- soft tissue defects in the dorsum of the digits;
- a defect < 2 cm in length;
- homodigital and heterodigital island flaps are available.
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 |
|---|---|---|
| Free dorsal digital flapThe dorsal digital flap, including both dorsal branches of the proper digital nerves, was designed on the dorsum of the donor finger between the distal third of the proximal phalanx and the distal interphalangeal joint. | Procedure or surgery | finger |
Primary outcome
static 2-point discrimination (2PD) test
Time frame: 25 months
The test points were at the centers of the radial and ulnar portions of the digital pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Free dorsal digital flap in people with Nerve Injury and Digital Pulp Defect, run by The Second Hospital of Tangshan.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
static 2-point discrimination (2PD) test (time frame: 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2024.