ContracturesNCT01700595
Preexpanded Perforator Flaps in Children
A study testing new technical intervention in people with Contractures and Scars, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Contractures, Scars
- What is being tested?
- new technical intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric age group
- broad scars and contractures
Who cannot join
- age over 18 years
- minimal scars and skin defects that could be treated by minor interventions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul, 34093
About this study
Official title: 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.
- Conditions
- Contractures, Scars
- Being tested
- new technical intervention
- Medical subject headings
- Contracture, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new technical interventionProcedure or surgery
Also called reconstructive surgery by transfer of preexpanded perforator flaps
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.
| Study group | Role | What they receive |
|---|---|---|
| new technical intervention | Experimental | ''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. Receives: Procedure: new technical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at least three months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Hocaoglu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700595
- Sponsor's protocol ID
- hocaoglupediatricperforator1
- Other IDs
- emrehocaoglu
- Status last verified
- Oct 2012
- First submitted
- 1 Oct 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preexpanded Perforator Flaps in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01700595
- Acronym / sponsor ID
- hocaoglupediatricperforator1
- Conditions
- Contractures, Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| new technical intervention | Experimental | Procedure: 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- pediatric age group
- broad scars and contractures
Key exclusion criteria (2 listed)
- age over 18 years
- minimal scars and skin defects that could be treated by minor interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| new technical interventionAlso: reconstructive surgery by transfer of preexpanded perforator flapsContractures 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. | Procedure or surgery | new technical intervention |
Primary outcome
Range of motion of the particular joint
Time frame: at least three months after flap tarnsfer
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.
1 secondary outcome
Replaced tissue dimensions
Time frame: at least three months after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Derived from this study: PubMed 23385985Hocaoglu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new technical intervention in people with Contractures and Scars, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion of the particular joint (time frame: at least three months after flap tarnsfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01700595, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.