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

• Sponsor: Istanbul University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01777386
• Collaborator: (none)
• Enrollment: 14
• Arms: 2
• Duration (Months): 43

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scar; Contracture; Flap Disorder	Procedure: preexpanded perforator flap surgery	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: preexpanded flap 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.	Procedure: preexpanded perforator flap surgery
No Intervention: control side In six of the 14 patients, perforator artery diameter of the nonexpanded symmetric anatomical side of the body (equivalent to the expanded site)were measured.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with broad scars and contracture bands

• patients with esophagocutaneous fistula

• patients with ambiguous genitalia

Exclusion Criteria:

• none

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Istanbul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emre Hocaoglu, Dr., Istanbul University
• ClinicalTrials.gov Identifier: NCT01777386
• Other Study ID Numbers: hocaoglupreexpandedperforator1
• First Posted: Jan 28, 2013
• Last Update Posted: Jan 29, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Emre Hocaoglu, Dr., Istanbul University: scar; contracture; perforator flap; preexpanded perforator flap; perforator vessel; artery diameter
• Additional relevant MeSH terms: Contracture

Study Results

No Results Posted as of Jan 29, 2013