Back to resultsRepair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
Primary Purpose
Infection Wound, Disruption of Nerve Repair
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nerve flap
Sponsored by
About this trial
This is an interventional treatment trial for Infection Wound focused on measuring defect;, dorsal branch of the proper digital nerve;, proper digital nerve;, finger sensory reconstruction.
Eligibility Criteria
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.
Sites / Locations
- The Second Hospital of Tangshan
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
nerve graft
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01707654
First Posted
October 12, 2012
Last Updated
October 25, 2018
Sponsor
The Second Hospital of Tangshan
1. Study Identification
Unique Protocol Identification Number
NCT01707654
Brief Title
Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
Official Title
Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Tangshan
4. Oversight
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Wound, Disruption of Nerve Repair
Keywords
defect;, dorsal branch of the proper digital nerve;, proper digital nerve;, finger sensory reconstruction.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nerve graft
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Nerve flap
Intervention Description
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.
Primary Outcome Measure Information:
Title
2-point Discrimination Test
Description
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.
Time Frame
17-25 months
Secondary Outcome Measure Information:
Title
Semmes-Weinstein (SW) Monofilament Test
Description
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.
Time Frame
17-25 months
Other Pre-specified Outcome Measures:
Title
Pain
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 (1-3 cm), moderate (4-6 cm) and severe (7-10 cm).
Time Frame
17-25 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
The Second Hospital of Tangshan
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
20888502
Citation
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.
Results Reference
result
PubMed Identifier
23829956
Citation
Chen 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.
Results Reference
derived
Learn more about this trial
Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
We'll reach out to this number within 24 hrs