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

Study Overview
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Brief Summary
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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.

Conditions
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Scar, Contracture, Flap Disorder

Intervention / Treatment
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* Procedure: preexpanded perforator flap surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with broad scars and contracture bands patients with esophagocutaneous fistula patients with ambiguous genitalia Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: preexpanded flap<br>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<br> <br> |
| No Intervention: control side<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transferred tissue dimensions | Demonstrating the amount of transferred healthy tissue exhibits the success of the technique. | At least five months after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scar, contracture, perforator flap, preexpanded perforator flap, perforator vessel, artery diameter