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

October 25, 2018 updated by: The Second Hospital of Tangshan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Tangshan, Hebei, China, 063000
        • The Second Hospital of Tangshan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Bilaterally innervated flap
Two nerve branches attached with the flap for sensory reconstruction.
Procedure: Flap including bilateral nerve branches
Two nerve branches are attached with the flap for sensory coverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static 2PD test
Time Frame: 18 months to 24 months after surgery
We use a Disk-Criminator to test two nearby points when touching the flap
18 months to 24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Tangshan

Collaborators

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimate)

June 19, 2014

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSChen10512
  • HBTS14-01502 (Other Identifier: Ethics Committee of Hebei)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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