Direct and Reversed Dorsal Digital Island Flaps: A Review of 65 Cases

Not Applicable

Completed

• Conditions: Soft Tissue Reconstruction; Sensory Restoration
• Interventions: Procedure: Direct and reversed dorsal digital island flap

• Registration Number: NCT02102035
• Lead Sponsor: The Second Hospital of Tangshan

Brief Summary

Reconstruction of soft tissue defects in the fingers continues to be a challenge problem. The study reports reconstruction of small to moderate defects of the fingers with the direct and reversed dorsal digital island flaps and evaluates the results of the use of the flaps.The main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap and joint motion.

Detailed Description

At final follow-up, sensory restoration of the flap is measured using the static 2-point discrimination (2PD) test and Semmes-Weinstein monofilament (SWM) test. Active motion of the joints is measured using a standard hand goniometer. For the direct DDIF, total active motion is calculated as the sum of degrees of active flexion of the interphalangeal and the metacarpophalangeal joints subtracted from the degrees of extension deficit. For the reversed DDIF, total active motion of the donor finger is calculated as the sum of degrees of active flexion of the proximal and distal interphalangeal joints subtracted from the degrees of extension deficit.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-09
• Status Verified: 2013-10
• Study Completion: 2014-02
• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-03-28
• Last Update Submitted: 2014-03-28
• Study First Posted: 2014-04-02
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• a defect greater than or equal to 1.5 cm in length
• the defects on the dorsal and lateral aspects of the fingers
• the defects located between the distal 1/2 of the middle phalanx and the tip of the finger
• a patient between 15 and 60 years of age.

Exclusion Criteria

• injuries involving the donor sites or the course of the vascular pedicle
• a defect less than 1.5 cm in length.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dorsal digital island flap	Direct and reversed dorsal digital island flap	The flap is used to cover the soft-tissue defects of the fingers.

Primary Outcome Measures

Name	Time	Method
Static 2-point discrimination test	16 to 24 months	The test points are at the center of the flap. Each area is tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stop at 4mm as a limit of static 2-point discrimination test and consider this normal.

Secondary Outcome Measures

Name	Time	Method
Total active motion	16-24 months	Active motion of the joints is measured using a standard hand goniometer. For the direct DDIF, total active motion is calculated as the sum of degrees of active flexion of the interphalangeal and the metacarpophalangeal joints subtracted from the degrees of extension deficit. For the reversed DDIF, TAM of the donor finger is calculated as the sum of degrees of active flexion of the proximal and distal interphalangeal joints subtracted from the degrees of extension deficit.

Trial Locations

Locations (1)

The Second Hospital of Tangshan; 🇨🇳 Tangshan, Hebei, China