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Sensory Reconstruction of Finger Pulp Defect Using a Dorsal Digital Island Flap

This study has been completed.
Sponsor:
Collaborators:
Chinese PLA General Hospital
The Second Hospital of Qinhuangdao
Information provided by (Responsible Party):
The Second Hospital of Tangshan
ClinicalTrials.gov Identifier:
NCT01486719
First received: December 4, 2011
Last updated: December 5, 2011
Last verified: December 2011
History of Changes
  Purpose

Sensory reconstruction of the finger pulp is a challenging problem. This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.


Condition Intervention
Trauma
 Procedure: Sensate Dorsal Digital Island Flap

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sensory Reconstruction of Finger Pulp Defect Using a Dorsal Digital Island Flap

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Second Hospital of Tangshan:

Primary Outcome Measures:
  • static 2-point discrimination test [ Time Frame: Patients were followed for 16-23 months (mean, 19 months) ] [ Designated as safety issue: No ]
    The patients were assessed at follow-up by an independent senior surgeon who did not attend the treatments. Evaluation included active range of motion (ROM) of the DIP and proximal interphalangeal (PIP ) joints, and static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test of the reconstructed finger pulps. These measurements were compared with those on the contralateral site. According to the Michigan Hand Outcomes Questionnaire (MHQ), patients reported their satisfaction with the appearance of the injured hand. The questions based on a 5-point response scale.


Secondary Outcome Measures:
  • Semmes-Weinstein monofilament test [ Time Frame: Patients were followed for 16-23 months (mean, 19 months) ] [ Designated as safety issue: No ]
    The patients were assessed at follow-up by an independent senior surgeon who did not attend the treatments. Evaluation included active range of motion (ROM) of the DIP and proximal interphalangeal (PIP ) joints, and static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test of the reconstructed finger pulps. These measurements were compared with those on the contralateral site.


Enrollment: 12
Study Start Date: February 2008
Study Completion Date: March 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Sensate Dorsal Digital Island Flap
    This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.
    Other Names:
    • Surgical Flap
    • Island Flap
Detailed Description:

From February 2008 to May 2009, the flap harvested from the dorsum of the middle phalanx of the same finger was used in 12 fingers in 12 patients. The flaps ranged in size from 2.0 × 2.0 cm to 2.8 × 2.2 cm. The mean pedicle length was 1.2 cm. Neurorrhaphy between the dorsal branches of the PDN and PDN was performed in both sides in all cases. Sensibility of the reconstructed finger pulp was evaluated by static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test. The range of motion of the donor fingers was measured. The data were compared to those of the opposite sides.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. a finger pulp defect > 1.5 cm in length
  2. necessity to preserve finger length
  3. patients younger than 60 years .

Exclusion Criteria:

  1. injury to the dorsum of the middle phalanx of the reconstructed finger that precluded its use as donor site
  2. injury to the course of the vascular pedicle or opposite PDA
  3. defects < 1.5 cm in length.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01486719     History of Changes
Other Study ID Numbers: CHEN-19750306
Study First Received: December 4, 2011
Last Updated: December 5, 2011
Health Authority: China: Ethics Committee

Keywords provided by The Second Hospital of Tangshan:
Finger pulp reconstruction
dorsal branch
proper digital nerve
palmar arterial arch
dorsal digital island flap

ClinicalTrials.gov processed this record on May 19, 2013