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

NCT ID: NCT01910298

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-29
• Study Completion Date: 2017-10-23

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Participants underwent immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ reconstructive tissue matrix (surgical mesh).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

Two Stage Breast Reconstruction

Participants underwent immediate, two-stage post-mastectomy breast reconstruction without reinforcement. Initial placement of a tissue expander that was inflated for approximately one to six months, and then replaced with an implant.

Group Type: ACTIVE_COMPARATOR

Two Stage Breast Reconstruction

Intervention Type: PROCEDURE

Interventions

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

Intervention Type: PROCEDURE

Two Stage Breast Reconstruction

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Female 18 years or older
• A candidate for both arms of the study involving immediate breast reconstruction post-skin sparing mastectomy (unilateral or bilateral) DTI with the use of Strattice™ Reconstructive Tissue Matrix (TM), 2 stage with use of Tissue Expander through exchange to Implant without support of a mesh or autologous tissue)
• An American Society of Anesthesiologists (ASA) Physical Status Classification of 1 or 2
• Estimated life expectancy > 3 years
• Able and willing to return for all scheduled and required study visits
• Able to provide written informed consent for study participation

Exclusion Criteria

• Clinically significant systemic disease, as determined by the Investigator, which could affect study participation or study results
• Received neo-adjuvant, inductive chemo-therapy (except Herceptin, or other targeted therapy) within 4 weeks prior to mastectomy
• Previous radiation therapy to either breast at any time
• Predicted permanent implant size that is greater than or equal to 500 grams (gms), per Investigator assessment
• Body mass index (BMI) <17 or > 30
• Co-morbid factors which predispose to postoperative infection, e.g. diabetes, collagen vascular disease, chronic steroid (except inhalers)/immunosuppressant use, immune deficiency, or co-existent infection
• Pregnant or lactating
• 3rd degree ptosis
• Prior breast surgery including breast reduction, augmentation, mastopexy, quadrectomy, and partial mastectomy with reduction of the skin envelope
• Prior use of a device (mesh or matrix) in the Breast
• Concomitant unrelated condition of breast/chest wall/skin that, as determined by the investigator, could adversely affect the surgical outcome (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
• Planned autologous tissue flap in addition to prosthetic implant
• Use of permanent expander implants such as Becker expanders or the Natrelle™ Permanent expander 150
• Current alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
• Currently enrolled or plans to enroll in another clinical trial unless it is: a registry, a retrospective study, a neo-adjuvant chemotherapy trial (as long as the chemotherapy regimen has been stopped 4 weeks prior to mastectomy), or a hormone/anti-hormonal therapy trial
• Any of the conditions identified within the labelled contraindications, i.e. sensitivity to porcine derived products or polysorbate 20.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

LifeCell

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donna Jacobs

Role: STUDY_CHAIR

Allergan

Locations

Institut Bergonie

Bordeaux, , France

Centre Oscar Lambret

Lille, , France

Institut du Cancer de Montpellier Val d'Aurelle

Montpellier, , France

L'Institut du Sein- Paris Breast Center

Paris, , France

Hopital Tenon APHP

Paris, , France

Universitätsklinikum Erlangen

Erlangen, , Germany

Kliniken Essen-Mitte

Essen, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitäts-Frauenklinik Heidelberg

Heidelberg, , Germany

Klinik der Universität München, Campus Innenstadt

Munich, , Germany

Klinikum rechts der Isar

Munich, , Germany

Asklepios Paulinen Klinik

Wiesbaden, , Germany

St Luke's hospital / Bradford Royal Infirmary (BRI)

Bradford, , United Kingdom

Dorset County Hospital

Dorchester, , United Kingdom

Frimley Park Hospital

Frimley, , United Kingdom

Wythenshawe Hospital UHSM NHS Foundation Trust

Manchester, , United Kingdom

City Hospital

Nottingham, , United Kingdom

Countries

France; Germany; United Kingdom

Other Identifiers

LFC 2012.06.01

Identifier Type: -

Identifier Source: org_study_id