NCT01136044

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
Last Updated

June 3, 2010

Status Verified

June 1, 2010

Enrollment Period

2.1 years

First QC Date

May 28, 2010

Last Update Submit

June 2, 2010

Conditions

Soft Tissue Defect

Keywords

tensor fasciae lataeseptocutaneous perforators

Outcome Measures

Primary Outcomes (1)

  • 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.

    January 2008 till may 2010

Interventions

septocutaneous perforator flapOTHER

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.

Also known as: fasciocutaneous flaps, perforator flap

Eligibility Criteria

Age16 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • soft tissue defect
  • no previous operations in the thigh region

You may not qualify if:

  • obese patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Division of Plastic Surgery

Graz, 8010, Austria

Location

Related Publications (1)

  • 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.

    PMID: 19568071BACKGROUND

MeSH Terms

Interventions

Perforator Flap

Intervention Hierarchy (Ancestors)

Surgical FlapsSurgically-Created StructuresEquipment and Supplies

Study Officials

  • Martin Hubmer, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2010

First Posted

June 3, 2010

Study Start

January 1, 2008

Primary Completion

February 1, 2010

Study Completion

May 1, 2010

Last Updated

June 3, 2010

Record last verified: 2010-06

Locations

AU(1)