Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

The Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction: A Prospective Analysis of 138 Flaps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106233
• Other study ID #: METC 14-5-095
• Status: Completed
• Phase: N/A
• First received: February 9, 2017
• Last updated: April 3, 2017
• Start date: September 2012
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recipient- and donor-site complications	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.	Through study completion up to an average of 12 months post-operatively
Secondary	Flap re-explorations	Total number of flaps that required a re-exploration because of arterial or venous insufficiency, hematoma or kinking of the pedicle.	Through study completion up to an average of 12 months post-operatively