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Preexpanded Perforator Flaps in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emre Hocaoglu, Istanbul University
ClinicalTrials.gov Identifier:
NCT01700595
First received: October 1, 2012
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

Contractures and broad scars of the axilla, anterior chest wall and neck have detrimental effects on functional, physical and psychological development of children. Perforator flaps have already been shown to be reliable options for the reconstruction of contractures but there have been no reports demonstrating the value of preexpanded perforator flaps of dorsolateral trunk region in treatment of extensive contractures and scars of pediatric patients. The purpose of this study is to demonstrate these techniques by a case series formed of pediatric patients with broad scars and contractures of anterior chest wall, axilla, neck and breasts. Seven pediatric patients (mean age, 11,6 years) who were treated by preexpanded perforator flaps are presented. By this means, clinical experience on intercostal artery perforator (ICAP) flap, thoracodorsal artery perforator (TDAP) flap, circumflex scapular artery perforator (CSAP) flap and lumbar artery perforator flap was shared. Flaps as large as 20,5x10,5 cm in size could be successfully transferred in pediatric patients. Broad scar tissues were resurfaced with broad flaps carrying similar characteristics with the uninjured anterior chest wall and neck skin in six of our patients. In one patient with partial necrosis, full thickness skin graft was used for the residual defect. The mean duration of postoperative (after flap transfer) follow-ups was 17,2 months. The preexpanded TDAP, ICAP and CSAP flaps are revealed to be useful reconstructive options for the treatment of scars and contractures of anterior chest wall, axilla, neck and breast in pediatric patients.


Condition Intervention
Contractures
Scars
 Procedure: new technical intervention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preexpanded Perforator Flaps in Pediatric Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Istanbul University:

Primary Outcome Measures:
  • Range of motion of the particular joint [ Time Frame: at least three months after flap tarnsfer ] [ Designated as safety issue: No ]
    Disruption of the contracture band and releasing the contracture of a particular joint results in achievement of the healthy range of motion of that joint.


Secondary Outcome Measures:
  • Replaced tissue dimensions [ Time Frame: at least three months after the operation ] [ Designated as safety issue: No ]
    Transferred flap sizes will be documented. It is a way of demonstrating the amount of replaced scar tissue and exhibiting the success of the technique.


Other Outcome Measures:
  • Developement of related anatomic structures [ Time Frame: at least a year after flap transfer ] [ Designated as safety issue: No ]
    Resurfacing the broad scar tissue and releasing the contracture leads to normal developement of the relevant extremity, chest, neck, breast and posture of the patient, thus, providing the healthy developement of the child.


Enrollment: 7
Study Start Date: September 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: new technical intervention
''new technical intervention'' represents the surgical procedure which is applied for the patients assigned to this group because of their certain characteristics. Namely, pediatric patients with broad axillary, anterior chest wall, mammary and neck scars are treated with this surgical approach.
 Procedure: new technical intervention
Contractures and broad scars of the subjects are treated by this surgical intervention which is a reconstructive surgery that is performed by the transfer of preexpanded perforator flaps to the recipient sites of skin deficiency.
Other Name: reconstructive surgery by transfer of preexpanded perforator flaps

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pediatric age group
  • broad scars and contractures

Exclusion Criteria:

  • age over 18 years
  • minimal scars and skin defects that could be treated by minor interventions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700595

Locations
Turkey
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Turkey, 34093
Sponsors and Collaborators
Istanbul University
  More Information

No publications provided

Responsible Party: Emre Hocaoglu, Specialist, M.D., Istanbul University
ClinicalTrials.gov Identifier: NCT01700595     History of Changes
Other Study ID Numbers: hocaoglupediatricperforator1, emrehocaoglu
Study First Received: October 1, 2012
Last Updated: October 2, 2012
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases

ClinicalTrials.gov processed this record on May 23, 2013