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

Soft Tissue Injuries Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167646
• Other study ID #: TSChen10512
• Secondary ID: HBTS14-01502
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: August 2013

Study information

• Verified date: February 2012
• Source: The Second Hospital of Tangshan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Soft Tissue Injuries

Intervention

Procedure:
• Flap including bilateral nerve branches
Two nerve branches are attached with the flap for sensory coverage

Locations

Country	Name	City	State
China	The Second Hospital of Tangshan	Tangshan	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Tangshan	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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-29e. doi: 10.1097/PRS.0000000000000016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static 2PD test	We use a Disk-Criminator to test two nearby points when touching the flap	18 months to 24 months after surgery