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

January 25, 2013 updated by: Emre Hocaoglu, Istanbul University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transferred tissue dimensions
Time Frame: At least five months after the operation
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
Time Frame: 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.
Measured the day before the expander implantation surgery and the day before the flap transfer surgery (second session following tissue expansion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hocaoglupreexpandedperforator1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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