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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

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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: LTP flap

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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction: A Prospective Analysis of 138 Flaps
Actual Study Start Date : September 2012
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female participants
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106233


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Stefania Tuinder, MD, PhD Maastricht University Medical Center
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Responsible Party: Rene van der Hulst, Prof. dr., Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03106233    
Other Study ID Numbers: METC 14-5-095
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rene van der Hulst, Maastricht University Medical Center:
Breast reconstruction
Perforator flap
Microsurgery