Infection WoundNCT01707654
Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
A study testing Nerve flap in people with Infection Wound and Disruption of Nerve Repair, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
A combination of soft tissue and digital nerve defects in the finger results in sensory loss of the finger pulp. Reconstruction of these combined injuries is difficult. When the neurocutaneous defect is associated with wound infection, reconstructive alternatives are more limited. Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection Wound, Disruption of Nerve Repair
- What is being tested?
- Nerve flap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- an infective wound with exposed bone or tendon in the finger;
- soft tissue defect involving proximal half of the middle phalanx, the proximal phalanx, or both;
- associated digital nerve defect 1 to 4 cm in length;
- single or double nerve defects; and
- simultaneous repair of nerve and soft tissue defects.
Who cannot join
- injury to the course of the pedicle or the donor site;
- nerve defect less than 1 cm or larger than 4 cm in length;
- occurrence of the defect in a region the flap is unable to reach, such as distal interphalangeal joint region, distal portion of the middle phalanx of the middle finger and the thumb;
- no involvement of the digital nerve.
Trial locations and contacts
1 site in 1 country.
About this study
A combination of soft tissue and digital nerve defects in the finger results in sensory loss of the finger pulp. Reconstruction of these combined injuries is difficult. When the neurocutaneous defect is associated with wound infection, reconstructive alternatives are more limited. From July 2008 to May 2010, a retrospective study was conducted with 9 consecutive postinfection patients who had the neurocutaneous defect of the finger following trauma. The purpose of this retrospective study is to report repair of the complicated infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of this technique.
Read the detailed description
sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.
- Conditions
- Infection Wound, Disruption of Nerve Repair
- Being tested
- Nerve flap
- Keywords
- defect;, dorsal branch of the proper digital nerve;, proper digital nerve;, finger sensory reconstruction.
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve flapDevice
Based on the Teoh et al.'s technique, we combined the nerve graft into the bipedicled heterodigital arterialized island flap and used this composite flap tissue for reconstructing complicated infected wound in the finger.
| Study group | Role | What they receive |
|---|---|---|
| nerve graft | Other | Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve. Receives: Device: Nerve flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-point Discrimination Test
The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.
Measured: 17-25 months
Secondary outcomes (1)
Semmes-Weinstein (SW) Monofilament Test
The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.
Measured: 17-25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startJul 2008
- Primary completionMay 2010
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infection WoundStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Tangshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707654
- Sponsor's protocol ID
- TSChen6017
- Other IDs
- HEBEI-J06451
- Status last verified
- Apr 2012
- First submitted
- 12 Oct 2012
- Last updated
- 21 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Chen C, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011.
PubMed 20888502Chen C, Tang P, Zhang L. Use of a bipedicled nerve flap taken from the dorsum of the digit for reconstruction of neurocutaneous defect in the adjacent finger. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1322-9. doi: 10.1016/j.bjps.2013.06.001. Epub 2013 Jul 2.
PubMed 23829956
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
- ClinicalTrials.gov ID
- NCT01707654
- Acronym / sponsor ID
- TSChen6017
- Conditions
- Infection Wound, Disruption of Nerve Repair
- Keywords
- defect;, dorsal branch of the proper digital nerve;, proper digital nerve;, finger sensory reconstruction.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Posted 23 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A combination of soft tissue and digital nerve defects in the finger results in sensory loss of the finger pulp. Reconstruction of these combined injuries is difficult. When the neurocutaneous defect is associated with wound infection, reconstructive alternatives are more limited. From July 2008 to May 2010, a retrospective study was conducted with 9 consecutive postinfection patients who had the neurocutaneous defect of the finger following trauma. The purpose of this retrospective study is to report repair of the complicated infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of this technique.
Detailed description
sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). Patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nerve graft | Other | Device: Nerve flapSimultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- an infective wound with exposed bone or tendon in the finger;
- soft tissue defect involving proximal half of the middle phalanx, the proximal phalanx, or both;
- associated digital nerve defect 1 to 4 cm in length;
- single or double nerve defects; and
- simultaneous repair of nerve and soft tissue defects.
Key exclusion criteria (4 listed)
- injury to the course of the pedicle or the donor site;
- nerve defect less than 1 cm or larger than 4 cm in length;
- occurrence of the defect in a region the flap is unable to reach, such as distal interphalangeal joint region, distal portion of the middle phalanx of the middle finger and the thumb;
- no involvement of the digital nerve.
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 |
|---|---|---|
| Nerve flapBased on the Teoh et al.'s technique, we combined the nerve graft into the bipedicled heterodigital arterialized island flap and used this composite flap tissue for reconstructing complicated infected wound in the finger. | Device | nerve graft |
Primary outcome
2-point Discrimination Test
Time frame: 17-25 months
The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.
1 secondary outcome
Semmes-Weinstein (SW) Monofilament Test
Time frame: 17-25 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20888502Chen C, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011.
- Derived from this study: PubMed 23829956Chen C, Tang P, Zhang L. Use of a bipedicled nerve flap taken from the dorsum of the digit for reconstruction of neurocutaneous defect in the adjacent finger. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1322-9. doi: 10.1016/j.bjps.2013.06.001. Epub 2013 Jul 2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve flap in people with Infection Wound and Disruption of Nerve Repair, 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 5 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 21 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
2-point Discrimination Test (time frame: 17-25 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 NCT01707654, which also lists 2 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 21 Nov 2018.