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CompletedNCT01700595Updated Oct 4, 2012

Preexpanded Perforator Flaps in Children

An interventional study of new technical intervention in Contractures and Scars, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2012-10-04.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study 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.

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Conditions studied

  • Contractures
  • Scars

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03

In context

Contracture

151 studies on the registry are indexed under Contracture; 21 are open to participants now.

This study's enrollment of 7 is below the median of 40 across 110 interventional studies indexed under Contracture.

Browse Contracture studies →

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • pediatric age group
  • broad scars and contractures

Exclusion criteria

Exclusion Criteria:

  • age over 18 years
  • minimal scars and skin defects that could be treated by minor interventions
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • 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

Interventions

  • Procedurenew 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.

    Also known as: reconstructive surgery by transfer of preexpanded perforator flaps

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: at least three months after flap tarnsfer

Secondary outcomes

  1. 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.

    Time frame: at least three months after the operation

Other outcomes

  1. Developement of related anatomic structures

    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

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Study locations

1 site
  • Istanbul University, Istanbul Faculty of Medicine
    Istanbul, 34093, Turkey
08

References and documents

Publications

  • 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. PubMed 23385985 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01700595
Lead sponsor
Istanbul University
Responsible party
Emre Hocaoglu (Specialist, M.D., Istanbul University) — Principal investigator
First posted
Oct 4, 2012
Start date
Sep 2012
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Oct 4, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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