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: August 18, 2013
Last verified: April 2012
Results First Received: June 3, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Infection Wound
Disruption of Nerve Repair
Intervention: Device: Nerve flap

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From July 2008 to May 2010, 9 patients who had a combination of soft tissue and digital nerve defects were included in the study. The type of location was medical clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No patient was lost to follow-up

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Nerve Graft  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Nerve Graft  
Number of Participants  
[units: participants]
  9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.6  ± 6.6  
Gender  
[units: participants]
 
Female     3  
Male     6  
Region of Enrollment  
[units: participants]
 
China     9  



  Outcome Measures

1.  Primary:   2-point Discrimination Test   [ Time Frame: 17-25 months ]

2.  Secondary:   Semmes-Weinstein (SW) Monofilament Test   [ Time Frame: 17–25 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Other Pre-specified:   Pain   [ Time Frame: 17–25 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Chao Chen
Organization: The Second Hospital of Tangshan
phone: 86-13700350471
e-mail: ts_chenchao@163.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01707654     History of Changes
Other Study ID Numbers: TSChen6017, HEBEI-J06451
Study First Received: October 12, 2012
Results First Received: June 3, 2013
Last Updated: August 18, 2013
Health Authority: United States: Food and Drug Administration
China: Ethics Committee