- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01700595
Preexpanded Perforator Flaps in Children
October 2, 2012 updated by: Emre Hocaoglu, Istanbul University
Preexpanded Perforator Flaps in Pediatric Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Istanbul, Turkey, 34093
- Istanbul University, Istanbul Faculty of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion of the particular joint
Time Frame: at least three months after flap tarnsfer
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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.
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at least three months after flap tarnsfer
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Replaced tissue dimensions
Time Frame: at least three months after the operation
|
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.
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at least three months after the operation
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Developement of related anatomic structures
Time Frame: at least a year after flap transfer
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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.
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at least a year after flap transfer
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
October 1, 2012
First Submitted That Met QC Criteria
October 2, 2012
First Posted (Estimate)
October 4, 2012
Study Record Updates
Last Update Posted (Estimate)
October 4, 2012
Last Update Submitted That Met QC Criteria
October 2, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- hocaoglupediatricperforator1
- emrehocaoglu (Registry Identifier: clinical trials)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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