ScarNCT01777386
Perforator Artery Changes During Suprafascial Pre-expansion of the Perforator Flaps
A study testing preexpanded perforator flap surgery in people with Scar and Contracture, run by Istanbul University.
Trial summary
Tissue expansion methods have been recommended as a means of improving the clinical results with perforator flaps but in plastic surgery literature there are few clinical trials supporting this opinion. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Scar, Contracture, Flap Disorder
- What is being tested?
- preexpanded perforator flap surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jan 2013
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with broad scars and contracture bands
- patients with esophagocutaneous fistula
- patients with ambiguous genitalia
Who cannot join
- none
About this study
Tissue expansion methods have been recommended as a means of improving the clinical results with perforator flaps but in plastic surgery literature there are few clinical trials supporting this opinion. The purposes of this clinical study are to address the ''preexpanded perforator flap concept'' by demonstrating a case series of relevant reconstructive procedures and to evaluate the perforator vessel changes that happen during the expansion periods of various perforator flap donor sites.
- Conditions
- Scar, Contracture, Flap Disorder
- Being tested
- preexpanded perforator flap surgery
- Keywords
- scar, contracture, perforator flap, preexpanded perforator flap, perforator vessel, artery diameter
- Medical subject headings
- Cicatrix, Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preexpanded perforator flap surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| preexpanded flap | Active comparator | Fourteen patients were treated with fifteen '' preexpanded perforator flap surgery '' interventions. The last six cases were evaluated in terms of perforator artery diameter before and after expansion process. The preexpanded flap donor sites' perforator artery diameters were also compared with their anatomic equivalents located in the symmetric side of the body. Receives: Procedure: preexpanded perforator flap surgery |
| control side | No intervention | In six of the 14 patients, perforator artery diameter of the nonexpanded symmetric anatomical side of the body (equivalent to the expanded site)were measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transferred tissue dimensions
Demonstrating the amount of transferred healthy tissue exhibits the success of the technique.
Measured: At least five months after the operation
Secondary outcomes (1)
Diameter of the perforator artery in a particular tissue level
This measurement will reveal one of the morphologic changes happen during tissue expansion period (perforator flap preexpansion). This measurement will be done for the last six patients. The diameter of the perforator artery of the preexpanded flap will be compared with both the diameter of the same artery before the expansion process and the diameter of the equivalent perforator artery of the symmetric side (non expanded side)of the body.
Measured: Measured the day before the expander implantation surgery and the day before the flap transfer surgery (second session following tissue expansion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJun 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT01777386
- Sponsor's protocol ID
- hocaoglupreexpandedperforator1
- Status last verified
- Jan 2013
- First submitted
- 18 Jan 2013
- Last updated
- 29 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perforator Artery Changes During Suprafascial Pre-expansion of the Perforator Flaps
- ClinicalTrials.gov ID
- NCT01777386
- Acronym / sponsor ID
- hocaoglupreexpandedperforator1
- Conditions
- Scar, Contracture, Flap Disorder
- Keywords
- scar, contracture, perforator flap, preexpanded perforator flap, perforator vessel, artery diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Jan 2013 (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.
Tissue expansion methods have been recommended as a means of improving the clinical results with perforator flaps but in plastic surgery literature there are few clinical trials supporting this opinion. The purposes of this clinical study are to address the ''preexpanded perforator flap concept'' by demonstrating a case series of relevant reconstructive procedures and to evaluate the perforator vessel changes that happen during the expansion periods of various perforator flap donor sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preexpanded flap | Active comparator | Procedure: preexpanded perforator flap surgeryFourteen patients were treated with fifteen '' preexpanded perforator flap surgery '' interventions. The last six cases were evaluated in terms of perforator artery diameter before and after expansion process. The preexpanded flap donor sites' perforator artery diameters were also compared with their anatomic equivalents located in the symmetric side of the body. |
| control side | No intervention | –In six of the 14 patients, perforator artery diameter of the nonexpanded symmetric anatomical side of the body (equivalent to the expanded site)were measured. |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients with broad scars and contracture bands
- patients with esophagocutaneous fistula
- patients with ambiguous genitalia
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| preexpanded perforator flap surgery | Procedure or surgery | preexpanded flap |
Primary outcome
Transferred tissue dimensions
Time frame: At least five months after the operation
Demonstrating the amount of transferred healthy tissue exhibits the success of the technique.
1 secondary outcome
Diameter of the perforator artery in a particular tissue level
Time frame: Measured the day before the expander implantation surgery and the day before the flap transfer surgery (second session following tissue expansion)
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 29 Jan 2013.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing preexpanded perforator flap surgery in people with Scar and Contracture, run by Istanbul University.
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 3 inclusion and 1 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 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Transferred tissue dimensions (time frame: At least five months after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2013.