Skip to main content
Clinical Trials/NCT01777386
NCT01777386CompletedNot Applicable

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

Istanbul University0 sites14 target enrollmentStarted: June 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
14
Primary Endpoint
Transferred tissue dimensions

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

preexpanded flap

Active Comparator

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.

Intervention: preexpanded perforator flap surgery (Procedure)

control side

No Intervention

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 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(Measured the day before the expander implantation surgery and the day before the flap transfer surgery (second session following tissue expansion))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emre Hocaoglu

Dr.

Istanbul University

Similar Trials