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

Sensory Restoration Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102035
• Other study ID #: TSChen8992
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: March 28, 2014
• Start date: January 2011
• Est. completion date: February 2014

Study information

• Verified date: October 2013
• Source: The Second Hospital of Tangshan
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sensory Restoration
• Soft Tissue Reconstruction

Intervention

Procedure:
• Direct and reversed dorsal digital island flap
The direct dorsal digital island flap is used to cover the defects of adjacent fingers. The reversed dorsal digital island flap is used to cover the defects of the same fingers.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Tangshan

Country where clinical trial is conducted

China, 

References & Publications (1)

Chen C, Tang P, Zhang L. Reconstruction of a soft tissue defect in the finger using the heterodigital neurocutaneous island flap. Injury. 2013 Nov;44(11):1607-14. doi: 10.1016/j.injury.2013.06.025. Epub 2013 Jul 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static 2-point discrimination test	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.	16 to 24 months	No
Secondary	Total active motion	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.	16-24 months	No