Efficacy of Single Stage Breast Reconstruction (ESSBR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by LifeCell
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT01910298
First received: July 22, 2013
Last updated: February 20, 2015
Last verified: February 2015
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • Number of clinically significant cases of capsular contracture as defined by Baker Grade III or IV [ Time Frame: 24 months post-permanent reconstruction ] [ Designated as safety issue: Yes ]
  • Aesthetic outcomes of subjects using blinded assessment 2D photographs by independent review panel [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    recorded per subject


Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: July 2017 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01910298

Contacts
Contact: Karl Breuing, MD, FACS +49 1520 367 5542 kbreuingmd@gmail.com

Locations
France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Dr. Marion Fournier, MD    +33 556 333 335    m.fournier@bordeaux.unicancer.fr   
Principal Investigator: Dr. Marion Fournier         
Centre Oscar Lambret Recruiting
Lille Cedex, France, 59000
Contact: Dr. Marie-Pierre Chauvet, MD    + 33 3 20 29 59 06    mp-chauvet@o-lambret.fr   
Principal Investigator: Dr. Marie-Pierre Chauvet         
ICM Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Marian Gutkowski, MD    +33 4 67 61 85 81    Marian.Gutkowski@icm.unicancer.fr   
Principal Investigator: Marian Gutkowski, MD         
Hopital Tenon APHP Recruiting
Paris, France
Contact: Dr. Michael Atlan    +33 1 56 01 62 53    drmichaelatlan@gmail.com   
Principal Investigator: Dr Michael Atlan         
L'Institut du Sein- Paris Breast Center Recruiting
Paris, France, 75116
Contact: Dr. Krishna Clough, MD    + 33 1 45 63 00 00    secret.kbc@idsein.fr   
Principal Investigator: Dr. Krishna Clough         
Germany
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: PD Dr. med. Michael Lux, MD    +49 9131 85-33553    Michael.Lux@uk-erlangen.de   
Principal Investigator: PD Dr. med. Michael Lux         
Brustzentrum klinikum, Kliniken Essen-Mitte, Active, not recruiting
Essen, Germany, 45131
Medizinische Hochschule Hannover Active, not recruiting
Hannover, Germany, 30625
Universitäts-Frauenklinik Heidelberg Recruiting
Heidelberg, Germany, 69115
Contact: Prof. Dr. med. Florian Schütz    +49 6221 563 7688    florian.schuetz@med.uni-heidelberg.de   
Principal Investigator: Prof. Dr. med. Florian Schuetz         
Klinik der Universität München, Campus Innenstadt Active, not recruiting
Munich, Germany, 80337
Klinikum rechts der Isar Active, not recruiting
Munich, Germany, 81675
Asklepios Paulinen Klinik Active, not recruiting
Wiesbaden, Germany, 65197
United Kingdom
St Luke's hospital / Bradford Royal Infirmary (BRI) Active, not recruiting
Bradford, United Kingdom, BD5 0NA
Frimley Park Hospital Active, not recruiting
Frimley, United Kingdom, GU16 7UJ
City Hospital Active, not recruiting
Nottingham, United Kingdom, NG5 1PB
Wythenshawe Hospital UHSM NHS Foundation Trust Active, not recruiting
Wythenshawe Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
LifeCell
Investigators
Principal Investigator: Karl Breuing, MD FACS No Current Affiliation
  More Information

No publications provided

Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT01910298     History of Changes
Other Study ID Numbers: LFC 2012.06.01
Study First Received: July 22, 2013
Last Updated: February 20, 2015
Health Authority: Germany: Ethics Commission
France: Institutional Ethical Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by LifeCell:
Breast reconstruction
Breast implant
Breast cancer
Mastectomy

ClinicalTrials.gov processed this record on March 31, 2015