A Comparison of Dorsal Branch of the Digital Nerve Versus Dorsal Digital Nerve for Finger Pulp Reconstruction

As the donor nerve attached with the flap, the dorsal branch of the digital nerve and the dorsal digital nerve is commonly used for finger pulp reconstruction.This study compares two donor nerves: the dorsal branch of the digital nerve and the dorsal digital nerve.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Defect of the Finger
• Intervention / Treatment: Procedure: flap includes a donor nerve

Detailed Description

The investigators compares two donor nerves attached with the flap for sensory reconstruction of finger pulp: the dorsal branch of the digital nerve and the dorsal digital nerve. The main outcomes were static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, and pain and cold intorlence of the reconstructed finger.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The pulp or fingertip defect in only one finger
• A defect greater than or equal to 1.5 cm in length
• Necessity to preserve finger length
• A patient between 18 and 60 years of age

Exclusion Criteria:

• Injuries to the dorsum of the middle phalanx
• Injuries to the course of the vascular pedicle or donor nerve
• A defect less than 1.5 cm in length
• Multiple finger pulp defect
• Extremely contaminated wounds

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Innervated finger flap; donor nerve attached with the flap for finger pulp reconstruction	Procedure: flap includes a donor nerve; the donor nerve is attached with the flap for sensory reconstruction of the finger

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
static 2-point discrimination (2PD) test	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. We stop at 4mm as a limit of 2PD and consider this normal.	18 months to 26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cold intolerance	Cold intolerance in the reconstructed finger is assessed using the self-administered Cold Intolerance Severity Score questionnaire [10]. The maximum score is 100 and was group into 4 ranges (0-25, 26-50, 51-75, and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.	18 months to 26 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Using the visual analogue scale (VAS), patients are asked to report pain sensations of the reconstructed pulps and donor sites. The VAS consists of a 10 cm line that is grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).	18 months to 26 months

Collaborators and Investigators

• Sponsor: The Second Hospital of Tangshan
• Collaborators: Chinese PLA General Hospital
• Investigators: Study Director: Dequn Liu, MD. PhD, The Second Hospital of Tangshan

Publications and helpful links

General Publications

• Chen C, Tang P, Zhang X. Use of the dorsal digital sensate free flap for reconstruction of volar soft tissue defect of digits. Ann Plast Surg. 2014 May;72(5):537-41. doi: 10.1097/SAP.0b013e318268a97f.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: April 1, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (Estimate): April 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 8, 2013
• Last Update Submitted That Met QC Criteria: April 5, 2013
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: dorsal branch of the digital nerve; Dorsal digital nerve; dorsal branch of the digital artery; dorsal digital island flap; finger pulp defect.
• Other Study ID Numbers: TSChen8652; HBTS13-03095 (Other Identifier: Ethics Committee of Hebei)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No