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

Primary Purpose

Soft Tissue Injuries

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Flap including bilateral nerve branches
Sponsored by
The Second Hospital of Tangshan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Injuries focused on measuring Soft tissue defect, dorsal branch of the digital nerve, dorsal branch of the digital artery, dorsal digital flap

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Second Hospital of Tangshan

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bilaterally innervated flap

Arm Description

Two nerve branches attached with the flap for sensory reconstruction.

Outcomes

Primary Outcome Measures

Static 2PD test
We use a Disk-Criminator to test two nearby points when touching the flap

Secondary Outcome Measures

Full Information

First Posted
June 17, 2014
Last Updated
October 25, 2018
Sponsor
The Second Hospital of Tangshan
Collaborators
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02167646
Brief Title
Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Tangshan
Collaborators
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 Semmes-Weinstein monofilament scores of the flap, fingertip pain and joint motion.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Injuries
Keywords
Soft tissue defect, dorsal branch of the digital nerve, dorsal branch of the digital artery, dorsal digital flap

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilaterally innervated flap
Arm Type
Other
Arm Description
Two nerve branches attached with the flap for sensory reconstruction.
Intervention Type
Procedure
Intervention Name(s)
Flap including bilateral nerve branches
Intervention Description
Two nerve branches are attached with the flap for sensory coverage
Primary Outcome Measure Information:
Title
Static 2PD test
Description
We use a Disk-Criminator to test two nearby points when touching the flap
Time Frame
18 months to 24 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
24675204
Citation
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.
Results Reference
result
PubMed Identifier
25304161
Citation
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.
Results Reference
derived

Learn more about this trial

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

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