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Soft Tissue InjuriesNCT02167646

Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers

A study testing Flap including bilateral nerve branches in people with Soft Tissue Injuries, 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

Sensory coverage in the finger continues to be a challenging problem. This study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.The main evaluated outcomes are static 2-point discrimination and… Read more about this study

Who is it for?
Ages 15 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Soft Tissue Injuries
What is being tested?
Flap including bilateral nerve branches
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteChina
Study dates
Jan 2008to Aug 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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • a soft-tissue defect in the areas where sensory return was considered important ●a defect with exposed bone or tendon in one finger
  • the defect associated with the transected digital nerves in both sides
  • a defect greater than 1.5 cm
  • a patient aged 15 to 60 years

Who cannot join

  • injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
  • injuries to the dorsal branches of the digital nerves that precluded its use as donor nerves attached with the flap
  • a defect less than or equal to 1.5 cm
  • patient age < 15 years or > 60 years

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

Sensory coverage in the finger continues to be a challenging problem. This study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.The main evaluated outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, fingertip pain and joint motion.

Read the detailed description

Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Tinel's sign was rated as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma.

Being tested
Flap including bilateral nerve branches
Keywords
Soft tissue defect, dorsal branch of the digital nerve, dorsal branch of the digital artery, dorsal digital flap
Medical subject headings
Soft Tissue Injuries

What participants receive

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

  • Flap including bilateral nerve branchesProcedure or surgery

    Two nerve branches are attached with the flap for sensory coverage

Study groups in NCT02167646
Study groupRoleWhat they receive
Bilaterally innervated flapOtherTwo nerve branches attached with the flap for sensory reconstruction.
Receives: Procedure: Flap including bilateral nerve branches

What is being measured

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

  1. Static 2PD test

    We use a Disk-Criminator to test two nearby points when touching the flap

    Measured: 18 months to 24 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2014 (estimated)
  2. Study startJan 2008
  3. Primary completionApr 2011
  4. Study completionAug 2013

Resources

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
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02167646
Sponsor's protocol ID
TSChen10512
Other IDs
HBTS14-01502
Status last verified
Feb 2012
First submitted
17 Jun 2014
Last updated
29 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Chen C, Tang P, Zhang X. The dorsal homodigital island flap based on the dorsal branch of the digital artery: a review of 166 cases. Plast Reconstr Surg. 2014 Apr;133(4):519e-529e. doi: 10.1097/PRS.0000000000000016.

    PubMed 24675204

  • Chen C, Tang P, Zhao G. Bilaterally innervated dorsal digital flap for sensory reconstruction of digits. Injury. 2014 Dec;45(12):2018-24. doi: 10.1016/j.injury.2014.09.012. Epub 2014 Sep 22.

    PubMed 25304161

Questions about this trial

What is this clinical trial studying?

A study testing Flap including bilateral nerve branches in people with Soft Tissue 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 4 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 29 Oct 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?

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 2PD test (time frame: 18 months to 24 months after surgery). 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 NCT02167646, 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 29 Oct 2018.

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