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

November 14, 2019 updated by: LifeCell

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Lille Cedex, France, 59000
        • Centre Oscar Lambret
      • Montpellier Cedex 5, France, 34298
        • Institut du Cancer de Montpellier Val d'Aurelle
      • Paris, France
        • Hôpital Tenon APHP
      • Paris, France, 75116
        • L'Institut du Sein- Paris Breast Center
  • Germany
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
      • Essen, Germany, 45131
        • Kliniken Essen-Mitte
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69115
        • Universitäts-Frauenklinik Heidelberg
      • Munich, Germany, 81675
        • Klinikum rechts der Isar
      • Munich, Germany, 80337
        • Klinik der Universität München, Campus Innenstadt
      • Wiesbaden, Germany, 65197
        • Asklepios Paulinen Klinik
  • United Kingdom
      • Bradford, United Kingdom, BD5 0NA
        • St Luke's hospital / Bradford Royal Infirmary (BRI)
      • Dorchester, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Frimley, United Kingdom, GU16 7UJ
        • Frimley Park Hospital
      • Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital UHSM NHS Foundation Trust
      • Nottingham, United Kingdom, NG5 1PB
        • City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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).
Procedure: Breast Reconstruction, Direct to Implant (DTI) with Strattice™
Active Comparator: 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.
Procedure: Two Stage Breast Reconstruction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS)
Time Frame: Up to 12 months post ISS
ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group.
Up to 12 months post ISS

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)
Time Frame: Up to 12 months post ISS
Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the infra-mammary fold (IMF). Serious BRRC were detected through review by a medical monitor. Surgical complications included: capsular contracture (Baker grade ≥ 3), infection (local or systemic), hematoma, seroma, inflammation, skin or flap necrosis, implant extrusion, malposition, malrotation, asymmetry, bottoming out.
Up to 12 months post ISS
Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)
Time Frame: Up to 24 months ppR
Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the IMF. Serious BRRC were detected through review by a medical monitor. BRRC were defined as: a) infection, local or systemic, b) hematoma, c) seroma, d) inflammation, e) skin or flap necrosis, f) capsular contraction as defined by Baker grade > 3, g) implant extrusion (loss or explants), and h) malposition, malrotation, asymmetry, and bottoming out.
Up to 24 months ppR
Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR
Time Frame: Up to 24 months ppR
The surgeon assessed the level of capsular contracture in the participant's breast using the Baker Breast Contracture Scale where: Grade I=breast is normally soft and looks natural, Grade II=breast is a little firm but looks normal, Grade III=breast is firm and looks abnormal and Grade IV= breast is hard, painful, and looks abnormal. Baker Grade III and IV were defined as clinically significant and are reported here. Data is presented for number of participants with capsular contracture per breast (right breast and left breast).
Up to 24 months ppR
Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS
Time Frame: Baseline up to 6 months post ISS
ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group.
Baseline up to 6 months post ISS
Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast
Time Frame: Within 24 months ppR
Surgical interventions were all planned and unplanned post-mastectomy surgical interventions per participant on the reconstructed breast, within 24 months of the ISS, which is defined as the DTI breast reconstruction with Strattice™ TM or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction.
Within 24 months ppR

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Health-related Quality of Life
Time Frame: At 3, 6, and 12 months post-mastectomy and at 4 months ppR
At 3, 6, and 12 months post-mastectomy and at 4 months ppR
Healthcare Resource Use Including Length of Hospital Stay and Clinic Visits
Time Frame: At 6 and 12 months post-mastectomy and at 24 months ppR
At 6 and 12 months post-mastectomy and at 24 months ppR
Time to Return to Work or Normal Daily Activities
Time Frame: 6 and 12 months post-mastectomy and 24 month ppR
6 and 12 months post-mastectomy and 24 month ppR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LifeCell

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Donna Jacobs, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LFC 2012.06.01

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