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

NCT01910298 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2019-12-04

Study results available
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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.

Conditions

  • Mastectomy and Breast Reconstruction

Interventions

PROCEDURE

Breast Reconstruction, Direct to Implant (DTI) with Strattice™

PROCEDURE

Two Stage Breast Reconstruction

Sponsors & Collaborators

  • LifeCell

    lead INDUSTRY

Principal Investigators

  • Donna Jacobs · Allergan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-29
Primary Completion
2016-08-31
Completion
2017-10-23

Countries

  • France
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01910298 on ClinicalTrials.gov