Back to resultsPerforator Artery Changes During Suprafascial Pre-expansion of the Perforator Flaps
Primary Purpose
Scar, Contracture, Flap Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
preexpanded perforator flap surgery
Sponsored by
About this trial
This is an interventional treatment trial for Scar focused on measuring scar, contracture, perforator flap, preexpanded perforator flap, perforator vessel, artery diameter
Eligibility Criteria
Inclusion Criteria:
- patients with broad scars and contracture bands
- patients with esophagocutaneous fistula
- patients with ambiguous genitalia
Exclusion Criteria:
- none
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
preexpanded flap
control side
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Transferred tissue dimensions
Demonstrating the amount of transferred healthy tissue exhibits the success of the technique.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01777386
Brief Title
Perforator Artery Changes During Suprafascial Pre-expansion of the Perforator Flaps
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar, Contracture, Flap Disorder
Keywords
scar, contracture, perforator flap, preexpanded perforator flap, perforator vessel, artery diameter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preexpanded flap
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control side
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
preexpanded perforator flap surgery
Primary Outcome Measure Information:
Title
Transferred tissue dimensions
Description
Demonstrating the amount of transferred healthy tissue exhibits the success of the technique.
Time Frame
At least five months after the operation
Secondary Outcome Measure Information:
Title
Diameter of the perforator artery in a particular tissue level
Description
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.
Time Frame
Measured the day before the expander implantation surgery and the day before the flap transfer surgery (second session following tissue expansion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with broad scars and contracture bands
patients with esophagocutaneous fistula
patients with ambiguous genitalia
Exclusion Criteria:
none
12. IPD Sharing Statement
Learn more about this trial
Perforator Artery Changes During Suprafascial Pre-expansion of the Perforator Flaps
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