Soft Tissue Defect of the FingerNCT01826539
A Comparison of Dorsal Branch of the Digital Nerve Versus Dorsal Digital Nerve for Finger Pulp Reconstruction
A study testing flap includes a donor nerve in people with Soft Tissue Defect of the Finger, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Defect of the Finger
- What is being tested?
- flap includes a donor nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Sep 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The pulp or fingertip defect in only one finger
- A defect greater than or equal to 1.5 cm in length
- Necessity to preserve finger length
- A patient between 18 and 60 years of age
Who cannot join
- Injuries to the dorsum of the middle phalanx
- Injuries to the course of the vascular pedicle or donor nerve
- A defect less than 1.5 cm in length
- Multiple finger pulp defect
- Extremely contaminated wounds
Trial locations and contacts
1 site in 1 country.
About this study
As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.
Read the detailed description
The investigators compares two donor nerves attached with the flap for sensory reconstruction of finger pulp: the dorsal branch of the digital nerve and the dorsal digital nerve. The main outcomes were static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and cold intorlence of the reconstructed finger.
- Conditions
- Soft Tissue Defect of the Finger
- Being tested
- flap includes a donor nerve
- Keywords
- Dorsal digital nerve, dorsal branch of the digital nerve, dorsal branch of the digital artery, dorsal digital island flap, finger pulp defect.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flap includes a donor nerveProcedure or surgery
the donor nerve is attached with the flap for sensory reconstruction of the finger
| Study group | Role | What they receive |
|---|---|---|
| Innervated finger flap | Other | donor nerve attached with the flap for finger pulp reconstruction Receives: Procedure: flap includes a donor nerve |
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 are at the center of the radial or ulnar portion of the pulp. Each area is tested 3 times with a Discriminator. We stop at 4mm as a limit of 2PD and consider this normal.
Measured: 18 months to 26 months
Secondary outcomes (1)
Cold intolerance
Cold intolerance in the reconstructed finger is assessed using the self-administered Cold Intolerance Severity Score questionnaire [10]. The maximum score is 100 and was group into 4 ranges (0-25, 26-50, 51-75, and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.
Measured: 18 months to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue Defect of the FingerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 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
- Investigators
- Dequn Liu, MD. PhD, Study director, The Second Hospital of Tangshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826539
- Sponsor's protocol ID
- TSChen8652
- Other IDs
- HBTS13-03095
- Status last verified
- Apr 2011
- First submitted
- 1 Apr 2013
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen C, Tang P, Zhang X. Use of the dorsal digital sensate free flap for reconstruction of volar soft tissue defect of digits. Ann Plast Surg. 2014 May;72(5):537-41. doi: 10.1097/SAP.0b013e318268a97f.
PubMed 23241796
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Dorsal Branch of the Digital Nerve Versus Dorsal Digital Nerve for Finger Pulp Reconstruction
- ClinicalTrials.gov ID
- NCT01826539
- Acronym / sponsor ID
- TSChen8652
- Conditions
- Soft Tissue Defect of the Finger
- Keywords
- Dorsal digital nerve, dorsal branch of the digital nerve, dorsal branch of the digital artery, dorsal digital island flap, finger pulp defect.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Apr 2013 (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.
As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.
Detailed description
The investigators compares two donor nerves attached with the flap for sensory reconstruction of finger pulp: the dorsal branch of the digital nerve and the dorsal digital nerve. The main outcomes were static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and cold intorlence of the reconstructed finger.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Innervated finger flap | Other | Procedure: flap includes a donor nervedonor nerve attached with the flap for finger pulp reconstruction |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The pulp or fingertip defect in only one finger
- A defect greater than or equal to 1.5 cm in length
- Necessity to preserve finger length
- A patient between 18 and 60 years of age
Key exclusion criteria (5 listed)
- Injuries to the dorsum of the middle phalanx
- Injuries to the course of the vascular pedicle or donor nerve
- A defect less than 1.5 cm in length
- Multiple finger pulp defect
- Extremely contaminated wounds
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 |
|---|---|---|
| flap includes a donor nervethe donor nerve is attached with the flap for sensory reconstruction of the finger | Procedure or surgery | Innervated finger flap |
Primary outcome
static 2-point discrimination (2PD) test
Time frame: 18 months to 26 months
The test points are at the center of the radial or ulnar portion of the pulp. Each area is tested 3 times with a Discriminator. We stop at 4mm as a limit of 2PD and consider this normal.
1 secondary outcome
Cold intolerance
Time frame: 18 months to 26 months
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 8 Apr 2013.
- Results publication: PubMed 23241796Chen C, Tang P, Zhang X. Use of the dorsal digital sensate free flap for reconstruction of volar soft tissue defect of digits. Ann Plast Surg. 2014 May;72(5):537-41. doi: 10.1097/SAP.0b013e318268a97f.
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.
Dequn Liu, MD. PhD study director
The Second Hospital of Tangshan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flap includes a donor nerve in people with Soft Tissue Defect of the Finger, run by The Second Hospital of Tangshan at 1 site in China.
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 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: finished, as of the sponsor's last update on 8 Apr 2013. 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 China. 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?
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: 18 months to 26 months). 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 NCT01826539, which also lists 1 linked publication.
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 8 Apr 2013.