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

NCT02102035 | Completed DMC

• 1 other identifier: TSChen8992
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Reconstruction; Sensory Restoration

Keywords

defect; dorsal branch of the proper digital nerve; dorsal digital island flap; sensory reconstruction.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Total active motion

  16-24 months

Study Arms (1)

Dorsal digital island flap

OTHER

The flap is used to cover the soft-tissue defects of the fingers.

Procedure: Direct and reversed dorsal digital island flap

Interventions

Direct and reversed dorsal digital island flap PROCEDURE

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.

Dorsal digital island flap

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Second Hospital of Tangshan: lead

Study Sites (1)

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

Location

Related 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.

  PMID: 23871427 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 2, 2014
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: February 1, 2014
• Last Updated: April 2, 2014

Record last verified: 2013-10

Locations

CN (1)