Status:
TERMINATED
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
Lead Sponsor:
LifeCell
Conditions:
Mastectomy and Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2017
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT01910298
Start Date
July 29 2013
End Date
October 23 2017
Last Update
December 4 2019
Active Locations (18)
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1
Institut Bergonie
Bordeaux, France, 33076
2
Centre Oscar Lambret
Lille, France, 59000
3
Institut du Cancer de Montpellier Val d'Aurelle
Montpellier, France, 34298
4
L'Institut du Sein- Paris Breast Center
Paris, France, 75116