Soft Tissue DefectNCT01136044
Clinical Experience With a Tensor Fasciae Latae Perforator Flap Based on Septocutaneous Perforators
A study testing septocutaneous perforator flap in people with Soft Tissue Defect, run by Medical University of Graz at 1 site in Austria.
Trial summary
The purpose of this study is to evaluate the possible harvest of a tensor fasciae latae flap based on septocutaneous perforators.This study should further confirm our data from an anatomical study concerning location, distribution, diameter and differentiation of the perforators. Read more about this study
- Who is it for?
- Ages 16 to 71 years
- Conditions the study is for
- Soft Tissue Defect
- What is being tested?
- septocutaneous perforator flap
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2008to May 2010
- 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 16 to 71 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- soft tissue defect
- no previous operations in the thigh region
Who cannot join
- obese patients
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the possible harvest of a tensor fasciae latae flap based on septocutaneous perforators.This study should further confirm our data from an anatomical study concerning location, distribution, diameter and differentiation of the perforators.
- Conditions
- Soft Tissue Defect
- Being tested
- septocutaneous perforator flap
- Keywords
- tensor fasciae latae, septocutaneous perforators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
septocutaneous perforator flapOther
Also called fasciocutaneous flaps, perforator flap
Perforator flaps can be based on septocutaneous or musculocutaneous perforators. If septocutaneous perforators are present, the harvest of these flaps is more straight forward and the dissection of the pedicle is easy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of the anatomical data in the clinical trial
Since the purpose of this study was to confirm our anatomical data in a clinical trial, the location, the differentiation and the diameter of the septocutaneous perforators has been measured and recorded during flap elevation.
Measured: January 2008 till may 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJan 2008
- Primary completionFeb 2010
- Study completionMay 2010
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 Soft Tissue DefectStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Martin Hubmer, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136044
- Sponsor's protocol ID
- MUG111
- Status last verified
- Jun 2010
- First submitted
- 28 May 2010
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hubmer MG, Schwaiger N, Windisch G, Feigl G, Koch H, Haas FM, Justich I, Scharnagl E. The vascular anatomy of the tensor fasciae latae perforator flap. Plast Reconstr Surg. 2009 Jul;124(1):181-189. doi: 10.1097/PRS.0b013e3181ab114c.
PubMed 19568071
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Experience With a Tensor Fasciae Latae Perforator Flap Based on Septocutaneous Perforators
- ClinicalTrials.gov ID
- NCT01136044
- Acronym / sponsor ID
- MUG111
- Conditions
- Soft Tissue Defect
- Keywords
- tensor fasciae latae, septocutaneous perforators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Jun 2010 (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.
The purpose of this study is to evaluate the possible harvest of a tensor fasciae latae flap based on septocutaneous perforators.This study should further confirm our data from an anatomical study concerning location, distribution, diameter and differentiation of the perforators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- soft tissue defect
- no previous operations in the thigh region
Key exclusion criteria (1 listed)
- obese patients
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 |
|---|---|---|
| septocutaneous perforator flapAlso: fasciocutaneous flaps, perforator flapPerforator flaps can be based on septocutaneous or musculocutaneous perforators. If septocutaneous perforators are present, the harvest of these flaps is more straight forward and the dissection of the pedicle is easy. | Other | – |
Primary outcome
Confirmation of the anatomical data in the clinical trial
Time frame: January 2008 till may 2010
Since the purpose of this study was to confirm our anatomical data in a clinical trial, the location, the differentiation and the diameter of the septocutaneous perforators has been measured and recorded during flap elevation.
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 3 Jun 2010.
- Background: PubMed 19568071Hubmer MG, Schwaiger N, Windisch G, Feigl G, Koch H, Haas FM, Justich I, Scharnagl E. The vascular anatomy of the tensor fasciae latae perforator flap. Plast Reconstr Surg. 2009 Jul;124(1):181-189. doi: 10.1097/PRS.0b013e3181ab114c.
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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.
Martin Hubmer, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing septocutaneous perforator flap in people with Soft Tissue Defect, run by Medical University of Graz at 1 site in Austria.
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 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 3 Jun 2010. 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 Austria. 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?
Confirmation of the anatomical data in the clinical trial (time frame: January 2008 till may 2010). 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 NCT01136044, 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 3 Jun 2010; AzTrials last refreshed its copy on 1 Nov 2026.