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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01777386
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : January 29, 2013
Information provided by (Responsible Party):
Emre Hocaoglu, 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.

Condition or disease Intervention/treatment Phase
Scar Contracture Flap Disorder Procedure: preexpanded perforator flap surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
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

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Responsible Party: Emre Hocaoglu, Dr., Istanbul University Identifier: NCT01777386     History of Changes
Other Study ID Numbers: hocaoglupreexpandedperforator1
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013
Keywords provided by Emre Hocaoglu, Istanbul University:
perforator flap
preexpanded perforator flap
perforator vessel
artery diameter
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Muscular Diseases