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

NCT01777386 | Completed

• 1 other identifier: hocaoglupreexpandedperforator1
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Scar; Contracture; Flap Disorder

Keywords

scar; contracture; perforator flap; preexpanded perforator flap; perforator vessel; artery diameter

Outcome Measures

Primary Outcomes (1)

• Transferred tissue dimensions

  Demonstrating the amount of transferred healthy tissue exhibits the success of the technique.

  At least five months after the operation

Secondary Outcomes (1)

• 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)

Study Arms (2)

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.

Procedure: preexpanded perforator flap surgery

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.

Interventions

preexpanded perforator flap surgery PROCEDURE

preexpanded flap

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Cicatrix; Contracture

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 28, 2013
• Study Start: June 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 29, 2013

Record last verified: 2013-01