Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction

• ClinicalTrials.gov Identifier: NCT03106233
• Recruitment Status: Completed
• First Posted: April 10, 2017
• Last Update Posted: April 10, 2017
• Sponsor: Maastricht University Medical Center
• 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

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

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