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Efficacy of Single Stage Breast Reconstruction (ESSBR)

This study has been terminated.
(The study is being terminated due to no enrollment in over one year in the control arm)
Information provided by (Responsible Party):
LifeCell Identifier:
First received: July 22, 2013
Last updated: March 13, 2017
Last verified: March 2017
This is a prospective, multicenter, non-randomized, parallel design comparing a primary efficacy endpoint between subjects undergoing immediate post-mastectomy breast reconstruction with a breast implant and Strattice™ Reconstructive Tissue Matrix (TM) and subjects undergoing immediate, two-stage post-mastectomy breast reconstruction, where the initially placed expander will be exchanged for a breast implant only, without any type of reinforcement.

Condition Intervention
Mastectomy and Breast Reconstruction
Procedure: Breast reconstruction, direct to implant with Strattice
Procedure: Two stage breast reconstruction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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 .

Resource links provided by NLM:

Further study details as provided by LifeCell:

Primary Outcome Measures:
  • Number of planned and unplanned post-mastectomy surgical interventions per subject on the reconstructed breast [ Time Frame: Within 12 months of the initial study surgery ]

Secondary Outcome Measures:
  • Number of subjects experiencing one or more serious breast reconstruction-related complications [ Time Frame: within 12 months of initial study surgery and within 24 months post-permanent reconstruction ]
  • Number of clinically significant cases of capsular contracture as defined by Baker Grade III or IV [ Time Frame: 24 months post-permanent reconstruction ]
  • Aesthetic outcomes of subjects using blinded assessment 2D photographs by independent review panel [ Time Frame: 24 months ]
  • Number of planned and unplanned post-mastectomy surgical interventions of the reconstructed breast [ Time Frame: within 6 months of the initial study surgery and 24 months post-permanent reconstruction ]

Other Outcome Measures:
  • Health-related Quality of Life [ Time Frame: At 3, 6, and 12 months post-mastectomy and at 24 months post-permanent reconstruction ]
    Measured through questionnaires (EQ-5D and Breast-Q)

  • Healthcare resource use including length of hospital stay and clinic visits [ Time Frame: At 6 and 12 months post-mastectomy and at 24 months post-permanent reconstruction ]
    Per subject, including expansion visits in the two stage reconstruction arm

  • Time to return to work or normal daily activities [ Time Frame: 6 and 12 months post-mastectomy and 24 month post-permanent reconstruction ]
    recorded per subject

Enrollment: 127
Study Start Date: July 2013
Estimated Study Completion Date: September 2017
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Breast reconstruction, direct to implant with Strattice
Subjects undergoing immediate post-mastectomy breast reconstruction with a breast implant and Strattice™
Procedure: Breast reconstruction, direct to implant with Strattice
Active Comparator: Two stage breast reconstruction
Subjects undergoing immediate, two-stage post-mastectomy breast reconstruction without reinforcement.
Procedure: Two stage breast reconstruction

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 direct to implant (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 reinforcement. The objective will be achieved by prospectively assessing the number of planned and unplanned post-mastectomy surgical interventions A 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Female 18 years or older
  2. 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 TM, 2 stage with use of Tissue Expander through exchange to Implant without support of a mesh or autologous tissue)
  3. An American Society of Anesthesiologists (ASA) Physical Status Classification of 1 or 2
  4. Estimated life expectancy > 3 years
  5. Able and willing to return for all scheduled and required study visits
  6. Able to provide written informed consent for study participation

Exclusion Criteria:

  1. Clinically significant systemic disease, as determined by the Investigator, which could affect study participation or study results
  2. Received neo-adjuvant, inductive chemo-therapy (except Herceptin, or other targeted therapy) within 4 weeks prior to mastectomy
  3. Previous radiation therapy to either breast at any time
  4. Predicted permanent implant size that is greater than or equal to 500 gms, per Investigator assessment
  5. BMI <17 or > 30
  6. 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
  7. Pregnant or lactating
  8. 3rd degree ptosis
  9. Prior breast surgery including: breast reduction, augmentation, mastopexy, quadrectomy, and partial mastectomy with reduction of the skin envelope
  10. Prior use of a device (mesh or matrix) in the Breast
  11. 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)
  12. Planned autologous tissue flap in addition to prosthetic implant
  13. Use of permanent expander implants such as Becker expanders or the Natrelle Anatomical Permanent expander 150
  14. Current alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
  15. 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
  16. Any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate 20.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01910298

Institut Bergonie
Bordeaux, France, 33076
Centre Oscar Lambret
Lille Cedex, France, 59000
ICM Val d'Aurelle
Montpellier, France, 34298
L'Institut du Sein- Paris Breast Center
Paris, France, 75116
Hopital Tenon APHP
Paris, France
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Brustzentrum klinikum, Kliniken Essen-Mitte,
Essen, Germany, 45131
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitäts-Frauenklinik Heidelberg
Heidelberg, Germany, 69115
Klinik der Universität München, Campus Innenstadt
Munich, Germany, 80337
Klinikum rechts der Isar
Munich, Germany, 81675
Asklepios Paulinen Klinik
Wiesbaden, Germany, 65197
United Kingdom
St Luke's hospital / Bradford Royal Infirmary (BRI)
Bradford, United Kingdom, BD5 0NA
Dorset County Hospital
Dorchester, United Kingdom, DT1 2JY
Frimley Park Hospital
Frimley, United Kingdom, GU16 7UJ
City Hospital
Nottingham, United Kingdom, NG5 1PB
Wythenshawe Hospital UHSM NHS Foundation Trust
Wythenshawe Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Principal Investigator: Karl Breuing, MD FACS No Current Affiliation
  More Information

Responsible Party: LifeCell Identifier: NCT01910298     History of Changes
Other Study ID Numbers: LFC 2012.06.01
Study First Received: July 22, 2013
Last Updated: March 13, 2017

Keywords provided by LifeCell:
Breast reconstruction
Breast implant
Breast cancer
Mastectomy processed this record on May 24, 2017