Complex Digital InjuriesNCT01837407
Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap
A study testing Composite Flap in people with Complex Digital Injuries, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous defect of the proximal phalanx. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Complex Digital Injuries
- What is being tested?
- Composite Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Mar 2013
- 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
- a neurocutaneous defect at the proximal phalanx
- a soft tissue defect on the volar, dorsal, and contiguous lateral aspects of adjacent fingers .associated digital nerve defect.
Who cannot join
- an injury involving the course of the arterial or venous pedicle; an injury involving donor site or donor nerve
- a soft tissue defect on the noncontiguous lateral aspects of adjacent fingers
- a nerve injury that is able to be repaired by primary neurorrhaphy
Trial locations and contacts
1 site in 1 country.
About this study
Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous defect of the proximal phalanx.
- Conditions
- Complex Digital Injuries
- Being tested
- Composite Flap
- Keywords
- Soft tissue loss, nerve defect, dorsal branch of the proper digital nerve, heterodigital arterialized nerve pedicle flap, Composite Flap, nerve flap, nerve transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite FlapProcedure or surgery
nerve transfer with the dorsal branch of the digital nerve
| Study group | Role | What they receive |
|---|---|---|
| Surgical flap | Other | The flap includes the nerve for repair of the soft tissue and nerve defects Receives: Procedure: Composite 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 are at the center of the radial or ulnar portion of the pulp. Each area is tested 3 times with a Discriminator. The investigators stop at 4mm as a limit of 2PD and consider this normal.
Measured: 18 months to 24 months
Secondary outcomes (1)
Cold Intolerance Severity Score (CISS) questionnaire.
The maximum score is 100 and is grouped 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 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startMar 2008
- Primary completionSep 2011
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complex Digital InjuriesStudies 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
- Participant
- Enrolment
- 9 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
- NCT01837407
- Sponsor's protocol ID
- TSChen8871
- Other IDs
- HBTS13-04102
- Status last verified
- Jun 2011
- First submitted
- 18 Apr 2013
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 X. Reconstruction of a neurocutaneous defect of the proximal phalanx with a heterodigital arterialised nerve pedicle flap. Injury. 2014 Apr;45(4):799-804. doi: 10.1016/j.injury.2013.09.034. Epub 2013 Sep 27.
PubMed 24125537
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap
- ClinicalTrials.gov ID
- NCT01837407
- Acronym / sponsor ID
- TSChen8871
- Conditions
- Complex Digital Injuries
- Keywords
- Soft tissue loss, nerve defect, dorsal branch of the proper digital nerve, heterodigital arterialized nerve pedicle flap, Composite Flap, nerve flap, nerve transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- Mar 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 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.
Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous defect of the proximal phalanx.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical flap | Other | Procedure: Composite FlapThe flap includes the nerve for repair of the soft tissue and nerve defects |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- a neurocutaneous defect at the proximal phalanx
- a soft tissue defect on the volar, dorsal, and contiguous lateral aspects of adjacent fingers .associated digital nerve defect.
Key exclusion criteria (3 listed)
- an injury involving the course of the arterial or venous pedicle; an injury involving donor site or donor nerve
- a soft tissue defect on the noncontiguous lateral aspects of adjacent fingers
- a nerve injury that is able to be repaired by primary neurorrhaphy
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 |
|---|---|---|
| Composite Flapnerve transfer with the dorsal branch of the digital nerve | Procedure or surgery | Surgical flap |
Primary outcome
Static 2-point discrimination test
Time frame: 18 months to 24 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. The investigators stop at 4mm as a limit of 2PD and consider this normal.
1 secondary outcome
Cold Intolerance Severity Score (CISS) questionnaire.
Time frame: 18 months 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 23 Apr 2013.
- 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 24125537Chen C, Tang P, Zhang X. Reconstruction of a neurocutaneous defect of the proximal phalanx with a heterodigital arterialised nerve pedicle flap. Injury. 2014 Apr;45(4):799-804. doi: 10.1016/j.injury.2013.09.034. Epub 2013 Sep 27.
Related trials for Complex Digital Injuries
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
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 Composite Flap in people with Complex Digital Injuries, 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 2 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 23 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 test (time frame: 18 months 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 NCT01837407, 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 23 Apr 2013.