Perforator Artery Changes During Suprafascial Pre-expansion of the Perforator Flaps

Not Applicable

Completed

• Conditions: Contracture; Scar; Flap Disorder
• Interventions: Procedure: preexpanded perforator flap surgery

• Registration Number: NCT01777386
• Lead Sponsor: Istanbul University

Brief Summary

Tissue expansion methods have been recommended as a means of improving the clinical results with perforator flaps but in plastic surgery literature there are few clinical trials supporting this opinion. The purposes of this clinical study are to address the ''preexpanded perforator flap concept'' by demonstrating a case series of relevant reconstructive procedures and to evaluate the perforator vessel changes that happen during the expansion periods of various perforator flap donor sites.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-01-23
• Last Update Submitted: 2013-01-25
• Study First Posted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• patients with broad scars and contracture bands
• patients with esophagocutaneous fistula
• patients with ambiguous genitalia

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preexpanded flap	preexpanded perforator flap surgery	Fourteen patients were treated with fifteen '' preexpanded perforator flap surgery '' interventions. The last six cases were evaluated in terms of perforator artery diameter before and after expansion process. The preexpanded flap donor sites' perforator artery diameters were also compared with their anatomic equivalents located in the symmetric side of the body.

Primary Outcome Measures

Name	Time	Method
Transferred tissue dimensions	At least five months after the operation	Demonstrating the amount of transferred healthy tissue exhibits the success of the technique.

Secondary Outcome Measures

Name	Time	Method
Diameter of the perforator artery in a particular tissue level	Measured the day before the expander implantation surgery and the day before the flap transfer surgery (second session following tissue expansion)	This measurement will reveal one of the morphologic changes happen during tissue expansion period (perforator flap preexpansion). This measurement will be done for the last six patients. The diameter of the perforator artery of the preexpanded flap will be compared with both the diameter of the same artery before the expansion process and the diameter of the equivalent perforator artery of the symmetric side (non expanded side)of the body.