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OpenTrials
Completed

NCT Number: NCT01777386

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

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.

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Key information

Age range

6 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

preexpanded perforator flap surgery

Procedure

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2013
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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