Soft Tissue Loss With Nerve DefectNCT01629602
Treatment of Soft Tissue Loss With Nerve Defect in the Finger Using the Boomerang Nerve Flap
A study testing the Boomerang Nerve Flap in people with Soft Tissue Loss With Nerve Defect, run by The Second Hospital of Tangshan.
Trial summary
Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory loss of the finger pulp. Reconstruction of these complex soft tissue defects continues to be a challenge problem. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Soft Tissue Loss With Nerve Defect
- What is being tested?
- the Boomerang Nerve Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Jun 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- soft tissue loss between the midpoint of the distal phalanx and PIP joint; - associated PDN defect 1 to 4 cm in length;
- single or double PDN defects;
- simultaneous repair of soft tissue loss and PDN defect.
Who cannot join
- injury to the course of the vascular pedicle or the donor nerve;
- PDN defect less than 1 cm or larger than 4 cm in length;
- direct PDN repair;
- thumb neurocutaneous defects.
About this study
Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory loss of the finger pulp. Reconstruction of these complex soft tissue defects continues to be a challenge problem. To resolve this problem, we combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. For comparison, we also collected a consecutive series of 32 patients with similar injury in the finger treated using a cross finger flap and a secondary free nerve graft.
Read the detailed description
The patients in this study group were required to meet all of the following criteria: soft tissue loss between the midpoint of the distal phalanx and PIP joint; associated PDN defect 1 to 4 cm in length; single or double PDN defects; and simultaneous repair of soft tissue loss and PDN defect. Patients were excluded when they had the following: injury to the course of the vascular pedicle or the donor site or the donor nerve; PDN defect less than 1 cm or larger than 4 cm in length; direct PDN repair; and thumb neurocutaneous defects.
- Conditions
- Soft Tissue Loss With Nerve Defect
- Being tested
- the Boomerang Nerve Flap
- Keywords
- defect;, dorsal branch of the proper digital nerve;, proper digital nerve;, vascularized nerve graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Boomerang Nerve FlapProcedure or surgery
The nerve branch was combined with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas.
| Study group | Role | What they receive |
|---|---|---|
| vascularized nerve graft | Experimental | The investigators combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. Receives: Procedure: the Boomerang Nerve Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
static 2-point discrimination test
The test points were at the centers of the radial and ulnar portions of the finger pulp, the flap and the donor sites separately.
Measured: from 18 to 24 months
Secondary outcomes (1)
Cold Intolerance Severity Score (CISS) questionnaire
The maximum score was 100 and was grouped into mild (0-25), moderate (26-50), severe (51-75) and extreme severity (76-100).
Measured: from 18 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJul 2008
- Primary completionMay 2010
- Study completionJun 2011
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 Loss With Nerve DefectStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 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
- NCT01629602
- Sponsor's protocol ID
- TSChen4112
- Status last verified
- May 2011
- First submitted
- 22 Jun 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen C, Tang P, Zhang X. Treatment of soft-tissue loss with nerve defect in the finger using the boomerang nerve flap. Plast Reconstr Surg. 2013 Jan;131(1):44e-54e. doi: 10.1097/PRS.0b013e3182729f5e.
PubMed 23271553
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Soft Tissue Loss With Nerve Defect in the Finger Using the Boomerang Nerve Flap
- ClinicalTrials.gov ID
- NCT01629602
- Acronym / sponsor ID
- TSChen4112
- Conditions
- Soft Tissue Loss With Nerve Defect
- Keywords
- defect;, dorsal branch of the proper digital nerve;, proper digital nerve;, vascularized nerve graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- Jul 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Jun 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.
Soft tissue loss with proper digital nerve (PDN) defect in the finger results in sensory loss of the finger pulp. Reconstruction of these complex soft tissue defects continues to be a challenge problem. To resolve this problem, we combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. For comparison, we also collected a consecutive series of 32 patients with similar injury in the finger treated using a cross finger flap and a secondary free nerve graft.
Detailed description
The patients in this study group were required to meet all of the following criteria: soft tissue loss between the midpoint of the distal phalanx and PIP joint; associated PDN defect 1 to 4 cm in length; single or double PDN defects; and simultaneous repair of soft tissue loss and PDN defect. Patients were excluded when they had the following: injury to the course of the vascular pedicle or the donor site or the donor nerve; PDN defect less than 1 cm or larger than 4 cm in length; direct PDN repair; and thumb neurocutaneous defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vascularized nerve graft | Experimental | Procedure: the Boomerang Nerve FlapThe investigators combined the nerve branch with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- soft tissue loss between the midpoint of the distal phalanx and PIP joint; - associated PDN defect 1 to 4 cm in length;
- single or double PDN defects;
- simultaneous repair of soft tissue loss and PDN defect.
Key exclusion criteria (4 listed)
- injury to the course of the vascular pedicle or the donor nerve;
- PDN defect less than 1 cm or larger than 4 cm in length;
- direct PDN repair;
- thumb neurocutaneous defects.
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 Boomerang Nerve FlapThe nerve branch was combined with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas. | Procedure or surgery | vascularized nerve graft |
Primary outcome
static 2-point discrimination test
Time frame: from 18 to 24 months
The test points were at the centers of the radial and ulnar portions of the finger pulp, the flap and the donor sites separately.
1 secondary outcome
Cold Intolerance Severity Score (CISS) questionnaire
Time frame: from 18 to 24 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 27 Jun 2012.
- Derived from this study: PubMed 23271553Chen C, Tang P, Zhang X. Treatment of soft-tissue loss with nerve defect in the finger using the boomerang nerve flap. Plast Reconstr Surg. 2013 Jan;131(1):44e-54e. doi: 10.1097/PRS.0b013e3182729f5e.
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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 the Boomerang Nerve Flap in people with Soft Tissue Loss With Nerve 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 3 inclusion and 4 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 27 Jun 2012. 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 test (time frame: from 18 to 24 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 NCT01629602, 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 27 Jun 2012.