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Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap

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ClinicalTrials.gov Identifier: NCT01837407
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
The Second Hospital of Tangshan

Brief Summary:
Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous defect of the proximal phalanx.

Condition or disease Intervention/treatment Phase
Complex Digital Injuries Procedure: Composite Flap Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : March 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Surgical flap
The flap includes the nerve for repair of the soft tissue and nerve defects
Procedure: Composite Flap
nerve transfer with the dorsal branch of the digital nerve




Primary Outcome Measures :
  1. Static 2-point discrimination test [ Time Frame: 18 months to 24 months ]
    The test points are at the center of the radial or ulnar portion of the pulp. Each area is tested 3 times with a Discriminator. The investigators stop at 4mm as a limit of 2PD and consider this normal.


Secondary Outcome Measures :
  1. Cold Intolerance Severity Score (CISS) questionnaire. [ Time Frame: 18 months to 24 months ]
    The maximum score is 100 and is grouped into 4 ranges (0-25, 26-50, 51-75, and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.


Other Outcome Measures:
  1. Visual analog scale [ Time Frame: 18 months to 24 months ]
    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).



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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a neurocutaneous defect at the proximal phalanx
  • a soft tissue defect on the volar, dorsal, and contiguous lateral aspects of adjacent fingers .associated digital nerve defect.

Exclusion Criteria:

  • an injury involving the course of the arterial or venous pedicle; an injury involving donor site or donor nerve
  • a soft tissue defect on the noncontiguous lateral aspects of adjacent fingers
  • a nerve injury that is able to be repaired by primary neurorrhaphy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837407


Locations
China, Hebei
The Second Hospital of Tangshan
Tangshan, Hebei, China, 063000
Sponsors and Collaborators
The Second Hospital of Tangshan
Chinese PLA General Hospital

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01837407     History of Changes
Other Study ID Numbers: TSChen8871
HBTS13-04102 ( Other Identifier: Ethics Committee of Hebei )
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: June 2011

Keywords provided by The Second Hospital of Tangshan:
Soft tissue loss
nerve defect
dorsal branch of the proper digital nerve
heterodigital arterialized nerve pedicle flap
Composite Flap
nerve flap
nerve transfer