Trial record 1 of 57 for:    Mammaplasty | Open Studies
Previous Study | Return to List | Next Study

Efficacy of Single Stage Breast Reconstruction (ESSBR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by LifeCell
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT01910298
First received: July 22, 2013
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

This is a prospective, multicenter, non-randomised, parallel design comparing a primary Efficacy and primary Safety 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.

The study objectives will be achieved by prospectively assessing the number of planned and unplanned post-mastectomy surgical interventions within 12 months of the mastectomy.

Direct to Implant (DTI) breast reconstruction will include the use of Strattice™ TM for reinforcement of tissue during surgery.

Two-stage breast reconstruction will include the initial placement of a tissue expander without mesh or flap reinforcement. The expander will be inflated over the next months, and then replaced with an implant.


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: Safety/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 [ Time Frame: Within 12 months of the initial study surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of breast-reconstruction related surgical complications [ Time Frame: At 6 and 12 months post-mastectomy and 24 months post-permanent reconstruction ] [ Designated as safety issue: Yes ]
    Analysed per breast and per subject.


Other Outcome Measures:
  • Number of planned and unplanned post-mastectomy surgical interventions [ Time Frame: At 6 months post-mastectomy and at 24 months post-permanent reconstruction ] [ Designated as safety issue: No ]
    Per breast and per subject

  • Quality of Life of subjects [ 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) and time to return to work or normal daily activities.

  • Number of hospital/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

  • Overall breast-mound reconstruction [ Time Frame: At 24 months post-permanent reconstruction ] [ Designated as safety issue: Yes ]
    From initial surgery to surgeon-subject agreement that reconstruction is complete.

  • Aesthetic outcomes of subjects [ Time Frame: At 12 months post-mastectomy at 12 months post-mastectomy and at 24 months post-permanent reconstruction ] [ Designated as safety issue: No ]
    Blinded assessment of 2D photographs by an independent reviewer panel

  • Surgeon satisfaction scores of subjects [ Time Frame: At 6 and 12 months post-mastectomy and 24 months post-permanent reconstruction ] [ Designated as safety issue: No ]
    Investigator assessment

  • Subject satisfaction scores [ Time Frame: At 6 and 12 months post-mastectomy and 24 months post-permanent reconstruction ] [ Designated as safety issue: No ]
    Subject assessment


Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2015 (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:

This prospective, multicenter, non-randomised, parallel design will assess the clinical outcomes of immediate single-stage breast reconstruction, DTI, with support of Strattice™ TM compared to immediate, two-stage breast reconstruction without support of any mesh or autologous flap. The two-stage reconstruction control arm comprises initial expander placement, followed by exchange of expander to a permanent implant at 1 to a maximum of 6 months after expander placement and fill.

All subjects will be undergoing immediate post-mastectomy breast reconstruction with partial or full muscle coverage of the implant. Study subjects who need to undergo radiotherapy post-mastectomy, either planned or unplanned, are also allowed to participate in the study.

  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 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 +49 201 17433509 k.breuing@kliniken-essen-mitte.de

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         
Centre René Gauducheau Recruiting
Nantes, Saint Herblain, Cedex, France, 44805
Contact: Dr. Virginie Bordes, MD    +33 2 40 67 99 28    Virginie.Bordes@ico.unicancer.fr   
Principal Investigator: Dr. Virginie Bordes         
Hopital Tenon APHP Recruiting
Paris, France
Contact: Dr. Michael Atlan         
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    krishna.clough@orange.fr   
Principal Investigator: Dr. Krishna Clough         
Germany
Universitätsklinikum Erlangen Not yet 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, Alfried Krupp Krankenhaus, Recruiting
Essen, Germany, 45131
Contact: Dr. Karl Breuing, MD, FACS    +49 201 17433509    k.breuing@kliniken-essen-mitte.de   
Principal Investigator: Dr. Karl Breuing         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: OA Dr. med. Ursula Hille-Betz, MD    +49511/532-9563    Hille-Betz.Ursula@mh-hannover.de   
Principal Investigator: OA Dr. med. Ursula Hille-Betz         
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         
Klinikum rechts der Isar Recruiting
Munich, Germany, 81675
Contact: Dr. med. Stefan Päpke, MD    +49 89 41405433    Stefan.Paepke@lrz.tum.de   
Principal Investigator: Dr. med. Stefan Paepke         
Klinik der Universität München, Campus Innenstadt Recruiting
Munich, Germany, 80337
Contact: PD Dr. med. Darius Dian, MD    +49 89 5160 4111    Darius.Dian@med.uni-muenchen.de   
Principal Investigator: PD Dr. med. Darius Dian         
Asklepios Paulinen Klinik Recruiting
Wiesbaden, Germany, 65197
Contact: Volker Heyl, MD    +49 611 847 2391    v.heyl@asklepios.com   
Principal Investigator: Dr. med. Volker Heyl         
United Kingdom
St Luke's hospital / Bradford Royal Infirmary (BRI) Recruiting
Bradford, United Kingdom, BD5 0NA
Contact: Mr. Rick Linforth    +44 1274 383787    Richard.Linforth@bthft.nhs.uk   
Principal Investigator: Mr. Richard Linforth         
Western General Hospital Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Prof. Mike Dixon    +44 131 537 2643    jmd@ed.ac.uk   
Principal Investigator: Prof. Mike Dixon         
Frimley Park Hospital Recruiting
Frimley, United Kingdom, GU16 7UJ
Contact: Mr. Raouf Daoud    +44 7951705595    raouf.daoud@fph-tr.nhs.uk   
Principal Investigator: Mr. Raouf Daoud         
City Hospital Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Mr. Douglas Macmillan    +44 115 969 1169    Douglas.Macmillan@nottingham.ac.uk   
Principal Investigator: Mr. Douglas Macmillan         
Wythenshawe Hospital UHSM NHS Foundation Trust Recruiting
Wythenshawe Manchester, United Kingdom, M23 9LT
Contact: Mr. Richard , Johnson    +44 (0)161 291 4432    richard.johnson@UHSM.NHS.UK   
Principal Investigator: Mr. Richard Johnson         
Sponsors and Collaborators
LifeCell
Investigators
Principal Investigator: Dr. Karl Breuing Interdisciplinary Breast Center - Clinic for Senology
  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: January 9, 2014
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 August 28, 2014