Sensory Reconstruction of the Volar Aspect of the FingerNCT01778296

Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap

A study testing the neurocutaneous island flap in people with Sensory Reconstruction of the Volar Aspect of the Finger and The Heterodigital Neurocutaneous Island Flap, run by The Second Hospital of Tangshan at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because of its similar quality to the original. The dorsal digital island flap can be used for repairing the defect of adjacent finger, but the limited length of the pedicle precludes its use for a more distal defect. Read more about this study

Who is it for?: Ages 15 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Sensory Reconstruction of the Volar Aspect of the Finger, The Heterodigital Neurocutaneous Island Flap
What is being tested?: the neurocutaneous island flap
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteChina
Study dates: Jan 2008to Oct 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 15 to 60 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

the soft tissue defects involving the middle phalanx, the proximal interphalangeal joint, or both;
a defect greater than or equal to 2 cm in length;
a patient between 15 and 60 years of age.

Who cannot join

concomitant injuries to the dorsal skin of the middle phalanx of adjacent finger that precluded its use as donor site;
injuries to the course of donor nerve branch;
a defect less than 1.5 cm in length;
a fingertip or pulp defect;
a soft tissue defect of the thumb.

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Hospital of Tangshan
Tangshan, Hebei, 063000

Other trials in China

About this study

Read the detailed description

At final follow-up, we measured the sensibility of the flaps using the Semmes-Weinstein monofilament test and the static 2-point discrimination 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. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stopped at 4mm as a limit of 2PD and considered this normal.

Conditions: Sensory Reconstruction of the Volar Aspect of the Finger, The Heterodigital Neurocutaneous Island Flap
Being tested: the neurocutaneous island flap
Keywords: Dorsal branch of the digital nerve;, dorsal digital artery;, dorsal digital island flap;, neurocutaneous island flap.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

the neurocutaneous island flapDevice
Also called dorsal digital island flap
The neurocutaneous island flap of the dorsal branch of the digital nerve can be used for repair the defects of the proximal and middle phalanxes of adjacent fingers.

Study groups in NCT01778296
Study group	Role	What they receive
Surgical flap	Experimental	The neurocutaneous island flap is based on the dorsal branch of the digital nerve Receives: Device: the neurocutaneous island flap

What is being measured

The primary outcome is the main question the study is designed to answer.

Discriminatory Sensation of the Flap
Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The 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 point is at the center of the flap. 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 stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up.
Measured: 18 months to 24 months

Secondary outcomes (1)

Cold Intolerance
We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100).
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.

Jan 2008Oct 2012

First posted29 Jan 2013 (estimated)
Study startJan 2008
Primary completionMar 2012
Study completionOct 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 (3)Papers the sponsor has linked to this study.
Other trials for Sensory Reconstruction of the Volar Aspect 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01778296
Sponsor's protocol ID: HBTS1301283
Other IDs: CHS1301-00146
Status last verified: May 2012
First submitted: 25 Jan 2013
Last updated: 14 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
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 20888502
Wang B, Zhao Y, Lu A, Chen C. Ulnar nerve deep branch compression by a ganglion: a review of nine cases. Injury. 2014 Jul;45(7):1126-30. doi: 10.1016/j.injury.2014.03.017. Epub 2014 Apr 3.
PubMed 24774037
Chen C, Tang P, Zhang L. Reconstruction of a soft tissue defect in the finger using the heterodigital neurocutaneous island flap. Injury. 2013 Nov;44(11):1607-14. doi: 10.1016/j.injury.2013.06.025. Epub 2013 Jul 18.
PubMed 23871427

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap
ClinicalTrials.gov ID: NCT01778296
Acronym / sponsor ID: HBTS1301283
Conditions: Sensory Reconstruction of the Volar Aspect of the Finger, The Heterodigital Neurocutaneous Island Flap
Keywords: Dorsal branch of the digital nerve;, dorsal digital artery;, dorsal digital island flap;, neurocutaneous island flap.
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: Jan 2008
Primary completion: Mar 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 29 Jan 2013 (estimated)
Results: Posted 18 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Surgical flap	Experimental	Device: the neurocutaneous island flapThe neurocutaneous island flap is based on the dorsal branch of the digital nerve

Who may qualify

Ages: 15 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

the soft tissue defects involving the middle phalanx, the proximal interphalangeal joint, or both;
a defect greater than or equal to 2 cm in length;
a patient between 15 and 60 years of age.

Key exclusion criteria (5 listed)

concomitant injuries to the dorsal skin of the middle phalanx of adjacent finger that precluded its use as donor site;
injuries to the course of donor nerve branch;
a defect less than 1.5 cm in length;
a fingertip or pulp defect;
a soft tissue defect of the thumb.

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 neurocutaneous island flapAlso: dorsal digital island flapThe neurocutaneous island flap of the dorsal branch of the digital nerve can be used for repair the defects of the proximal and middle phalanxes of adjacent fingers.	Device	Surgical flap

Primary outcome

Discriminatory Sensation of the Flap
Time frame: 18 months to 24 months
Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The 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 point is at the center of the flap. 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 stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up.

1 secondary outcome

Cold Intolerance
Time frame: 18 months to 24 months

Results and safety

Results posted to the registry on 18 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Surgical Flap	12	12

Primary outcome: Discriminatory Sensation of the Flap

Time frame: 18 months to 24 months. Mean (Standard Deviation). Unit: mm

Measure	Surgical Flap n = 12
Value	8.3 (1.6)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: One year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Surgical Flap	0 of 12 (0%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): The samples of our study are small, and the results may change as our experience grows.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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 24774037Wang B, Zhao Y, Lu A, Chen C. Ulnar nerve deep branch compression by a ganglion: a review of nine cases. Injury. 2014 Jul;45(7):1126-30. doi: 10.1016/j.injury.2014.03.017. Epub 2014 Apr 3.
Derived from this study: PubMed 23871427Chen C, Tang P, Zhang L. Reconstruction of a soft tissue defect in the finger using the heterodigital neurocutaneous island flap. Injury. 2013 Nov;44(11):1607-14. doi: 10.1016/j.injury.2013.06.025. Epub 2013 Jul 18.

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?

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 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 14 Feb 2024. 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 18 Nov 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?

Discriminatory Sensation of the Flap (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 NCT01778296, which also lists 3 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 14 Feb 2024.