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

LifeCell

Status: Terminated

Conditions: Mastectomy and Breast Reconstruction

Treatments: Procedure: Breast Reconstruction, Direct to Implant (DTI) with Strattice™; Procedure: Two Stage Breast Reconstruction

Study type: Interventional

Funder types: Industry

Identifiers

NCT01910298

LFC 2012.06.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

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

Two Stage Breast Reconstruction

Active Comparator group

Description:

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.

Treatment:

Procedure: Two Stage Breast Reconstruction