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Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106233
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Rene van der Hulst, Maastricht University Medical Center

Tracking Information
First Submitted Date February 9, 2017
First Posted Date April 10, 2017
Last Update Posted Date April 10, 2017
Actual Study Start Date September 2012
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2017)
Recipient- and donor-site complications [ Time Frame: Through study completion up to an average of 12 months post-operatively ]
Recipient site: Total flap loss, partial flap loss, venous congestion, infection, hematoma, seroma, fat necrosis and wound complications. Donor site: Infection, hematoma, seroma, fat necrosis, wound complications.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 3, 2017)
Flap re-explorations [ Time Frame: Through study completion up to an average of 12 months post-operatively ]
Total number of flaps that required a re-exploration because of arterial or venous insufficiency, hematoma or kinking of the pedicle.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction
Official Title The Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction: A Prospective Analysis of 138 Flaps
Brief Summary The lateral thigh perforator (LTP) flap was previously introduced as an alternative flap for autologous breast reconstruction when the abdomen is not suitable as a donor site. In this prospective study all LTP flap breast reconstructions that have been performed since September 2012 are analyzed. In addition, the surgical refinements that were introduced over the years are reported.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All female patients who opted for autologous breast reconstruction but who required an alternate flap than the deep inferior epigastric artery perforator (DIEP) flap.
Condition Breast Cancer
Intervention Procedure: LTP flap
A flap is harvested from the upper lateral thigh region based on septocutaneous perforators located in the posterior septum between the tensor fascia latae and gluteus medius muscles.
Other Names:
  • Lateral thigh perforator flap
  • Septocutaneous tensor fasciae latae (sc-TFL) flap
Study Groups/Cohorts LTP flap breast reconstruction
All consecutive patients who underwent LTP flap breast reconstructions (unilateral, bilateral or stacked unilateral) between September 2012 and November 2016 at three centers in Maastricht, the Netherlands, and New York and New Orleans, the United States, were included. Autologous breast reconstruction was performed by using the upper lateral thigh region as a donor site.
Intervention: Procedure: LTP flap
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 3, 2017)
86
Original Actual Enrollment Same as current
Actual Study Completion Date December 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Lateral thigh region suitable as a donor site
  • Abdomen not suitable as donor site
  • Informed consent

Exclusion Criteria:

  • Pre-operative imaging showing no suitable perforators
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only female participants
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03106233
Other Study ID Numbers METC 14-5-095
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Rene van der Hulst, Maastricht University Medical Center
Study Sponsor Maastricht University Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Stefania Tuinder, MD, PhD Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date April 2017