The Second Hospital of Tangshan
Tangshan, Hebei, 063000, China
Completed
NCT Number: NCT02102035
Direct and Reversed Dorsal Digital Island Flaps: A Review of 65 Cases
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.
Completed
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Notify MeKey information
Conditions
Age range
15 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Direct and reversed dorsal digital island flap
ProcedureThe 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.
Primary outcomes
-
Static 2-point discrimination test
Time frame: 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 outcomes
-
Total active motion
Time frame: 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.
Sponsors and collaborators
Lead sponsor
The Second Hospital of Tangshan
Other
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2013
- Study completion
- 2014
- First posted
- Apr 2, 2014
- Registry last updated
- Apr 2, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.