Viewing Study NCT01927003


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Study NCT ID: NCT01927003
Status: COMPLETED
Last Update Posted: 2018-10-29
First Post: 2013-08-19
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases
Sponsor: The Second Hospital of Tangshan
Organization:

Study Overview

Official Title: Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases
Status: COMPLETED
Status Verified Date: 2010-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Multiple digital injuries are often complex and severe, and the commonly used local and regional flaps may not be feasible. The authors reconstruct soft tissue defects of the fingers using the dorsal digito-metacarpal flap and evaluate the efficacy of this technique.
Detailed Description: At final follow-up, we measure the sensibility of the flaps using the static 2-point discrimination test. The Static 2-point discrimination test determines the minimal distance at which a subject can sense the presence of two needle. The modified American Society for Surgery of the Hand guidalines are used to stratify discriminator measurements(excellent \<6 mm, good 6-10 mm, fair 11-15 mm, poor \>15 mm). Each area is tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers are considered proof of perception before proceeding to another lower value. We stopp at 4mm as a limit of 2PD and consider this normal. The measurements are performed at a single time point at final follow up.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
CHS130-00215 OTHER Hebei Clinical Trail Committee View