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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emre Hocaoglu, Istanbul University
ClinicalTrials.gov Identifier:
NCT01777386
First received: January 18, 2013
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Scar
Contracture
Flap Disorder
 Procedure: preexpanded perforator flap surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by Istanbul University:

Primary Outcome Measures:
  • Transferred tissue dimensions [ Time Frame: At least five months after the operation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Measured the day before the expander implantation surgery and the day before the flap transfer surgery (second session following tissue expansion) ] [ Designated as safety issue: No ]
    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.


Enrollment: 14
Study Start Date: June 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Emre Hocaoglu, Dr., Istanbul University
ClinicalTrials.gov Identifier: NCT01777386     History of Changes
Other Study ID Numbers: hocaoglupreexpandedperforator1
Study First Received: January 18, 2013
Last Updated: January 25, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Istanbul University:
scar
contracture
perforator flap
 preexpanded perforator flap
perforator vessel
artery diameter

Additional relevant MeSH terms:
Contracture
Cicatrix
Joint Diseases
Musculoskeletal Diseases
 Muscular Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013