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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Notify MeKey information
Conditions
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
Primary outcomes
-
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
-
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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