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

Scar Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777386
• Other study ID #: hocaoglupreexpandedperforator1
• Status: Completed
• Phase: N/A
• First received: January 18, 2013
• Last updated: January 25, 2013
• Start date: June 2009
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with broad scars and contracture bands

• patients with esophagocutaneous fistula

• patients with ambiguous genitalia

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Flap Disorder
• Scar

Intervention

Procedure:
• preexpanded perforator flap surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transferred tissue dimensions	Demonstrating the amount of transferred healthy tissue exhibits the success of the technique.	At least five months after the operation	No
Secondary	Diameter of the perforator artery in a particular tissue level	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.	Measured the day before the expander implantation surgery and the day before the flap transfer surgery (second session following tissue expansion)	No