NCT01910298

Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy

A Prospective, Multicenter, Controlled Study of Implant-based Breast Reconstruction, Measuring the Safety, Efficacy and Outcomes, of Immediate Single Stage Breast Reconstruction With Strattice™ Reconstructive Tissue Matrix Versus Immediate Two Stage Breast Reconstruction Without Strattice™ TM (ESSBR-Efficacy of Single Stage Breast Reconstruction)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: LifeCell · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant only, without any type of reinforcement.

Detailed description

The primary objective of this study is to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice™ TM, otherwise referred to as DTI as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander will be exchanged for a breast implant only, without any type of a reinforcement. The objective will be achieved by prospectively assessing the number of planned and unplanned post-mastectomy surgical interventions within 12 months of the mastectomy. Two-stage breast reconstruction will include the initial placement of a tissue expander in a total or partial submuscular position. In the case of partial muscle coverage, this will be without the support of any mesh or autologous flap to reinforce the lower pole. The expander will be inflated over approximately the next one to six months, and then replaced with an implant.

Conditions

• Mastectomy and Breast Reconstruction

Interventions

Type	Name	Description
PROCEDURE	Breast Reconstruction, Direct to Implant (DTI) with Strattice™
PROCEDURE	Two Stage Breast Reconstruction

Timeline

• Start date: 2013-07-29
• Primary completion: 2016-08-31
• Completion: 2017-10-23
• First posted: 2013-07-29
• Last updated: 2019-12-04
• Results posted: 2019-12-04

Locations

18 sites across 3 countries: France, Germany, United Kingdom