Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

The Second Hospital of Tangshan

ClinicalTrials.gov Identifier:

NCT01707654

First received: October 12, 2012

Last updated: October 15, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 12, 2012
Last Updated Date	October 15, 2012
Start Date ^ICMJE	July 2008
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 15, 2012)	2-point discrimination test [ Time Frame: 17-25 months ] [ Designated as safety issue: No ] 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). We stopped at 4mm as a limit of 2PD and considered this normal.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01707654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 15, 2012)	Semmes-Weinstein (SW) monofilament test [ Time Frame: 17-25 months ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE (submitted: October 15, 2012)	Pain [ Time Frame: 17-25 months ] [ Designated as safety issue: No ] 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 (1-3 cm), moderate (4-6 cm) and severe (7-10 cm).
Original Other Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
Official Title ^ICMJE	Not Provided
Brief 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. 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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Infection Wound Disruption of Nerve Repair
Intervention ^ICMJE	Device: Nerve flap 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 Arm (s)	nerve graft 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. Intervention: Device: Nerve flap
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	9
Completion Date	February 2012
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Both
Ages	16 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01707654
Other Study ID Numbers ^ICMJE	TSChen6017, HEBEI-J06451
Has Data Monitoring Committee	Not Provided
Responsible Party	The Second Hospital of Tangshan
Study Sponsor ^ICMJE	The Second Hospital of Tangshan
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	The Second Hospital of Tangshan
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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