Mastectomy - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

LifeCell

Recruitment countries:

France,  Germany,  United Kingdom

Health condition studied:

Mastectomy and Breast Reconstruction

URL:

Link to the clinical trial website

About the trial

Interventions:

Intervention 1: Procedure: Breast reconstruction, direct to implant with Strattice Intervention 2: Procedure: Two stage breast reconstruction

Key inclusion and exclusion 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 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.

• Age minimum:  18 Years
• Age maximum:  no maximum age
• Gender:  Female

Primary outcomes:

- Number of planned and unplanned post-mastectomy surgical interventions per subject; time frame: Within 12 months of the initial study surgery

Secondary outcomes:

- Number of breast-reconstruction related surgical complications; time frame: At 6 and 12 months post-mastectomy and 24 months post-permanent reconstruction; Analysed per breast and per subject.

Target sample size:

200

Study type:

interventional

Study design:

Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Active control (effective treament of control group). Assignment: Parallel. Study design purpose: Treatment;

Contacts:

• Name:  Dr. Karl Breuing
• Address: 
• Phone: 
• Email: 
• Affiliation:  Interdisciplinary Breast Center - Clinic for Senology

• Name:  Karl Breuing, MD, FACS
• Address: 
• Phone:  +49 201 17433509
• Email:  k.breuing@kliniken-essen-mitte.de
• Affiliation: 

Technical details

Scientific 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 . - ESSBR

Sources of monetary support:

LifeCell EMEA

Secondary sponsors:

Main ID:

DRKS00005440

Secondary ID:

LFC 2012.06.01
NCT01910298

Register:

German Clinical Trials Register

Date of registration:

19/02/2014

Date of first enrollment:

31/07/2013

Last refreshed:

19 June 2017