Preexpanded Perforator Flaps in Children
Primary Purpose
Contractures, Scars
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
new technical intervention
Sponsored by
About this trial
This is an interventional treatment trial for Contractures
Eligibility 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
Sites / Locations
- Istanbul University, Istanbul Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
new technical intervention
Arm Description
''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.
Outcomes
Primary Outcome Measures
Range of motion of the particular joint
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01700595
Brief Title
Preexpanded Perforator Flaps in Children
Official Title
Preexpanded Perforator Flaps in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contractures, Scars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
new technical intervention
Arm Type
Experimental
Arm Description
''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.
Intervention Type
Procedure
Intervention Name(s)
new technical intervention
Other Intervention Name(s)
reconstructive surgery by transfer of preexpanded perforator flaps
Intervention Description
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.
Primary Outcome Measure Information:
Title
Range of motion of the particular joint
Description
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.
Time Frame
at least three months after flap tarnsfer
Secondary Outcome Measure Information:
Title
Replaced tissue dimensions
Description
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.
Time Frame
at least three months after the operation
Other Pre-specified Outcome Measures:
Title
Developement of related anatomic structures
Description
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.
Time Frame
at least a year after flap transfer
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Istanbul University, Istanbul Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
23385985
Citation
Hocaoglu E, Aydin H. Preexpanded perforator flaps of the dorsolateral trunk in pediatric patients. Plast Reconstr Surg. 2013 May;131(5):1077-1086. doi: 10.1097/PRS.0b013e3182865dd7.
Results Reference
derived
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Preexpanded Perforator Flaps in Children
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