Efficacy of Single Stage Breast Reconstruction | Stopped
Efficacy of Single Stage Breast Rec... | Stopped
Efficacy of Single Stage Breast Reconstruction
ESSBR

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Medical Conditions
  • Mastectomy and Breast Reconstruction
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Stopped
Trial source and source ID number
NCT01910298

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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.
Research Details
  • 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.
Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Procedure : Breast reconstruction, direct to implant with Strattice, Procedure : Two stage breast reconstruction

Study Arm Groups : Breast reconstruction, direct to implant with Strattice, Two stage breast reconstruction

Intervention Type
See Interventions above
Primary Outcome Measures
    Number of planned and unplanned post-mastectomy surgical interventions per subject on the reconstructed breast; Within 12 months of the initial study surgery
Secondary Outcome Measures
    Number of subjects experiencing one or more serious breast reconstruction-related complications; 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; 24 months post-permanent reconstruction; Aesthetic outcomes of subjects using blinded assessment 2D photographs by independent review panel; 24 months; Number of planned and unplanned post-mastectomy surgical interventions of the reconstructed breast; within 6 months of the initial study surgery and 24 months post-permanent reconstruction
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Nottingham
Nottinghamshire
NG5 1PB
Novartis Investigative Site
Frimley
GU16 7UJ
Dorset County Hospital
Dorchester
England
DT1 2JY
Bradford
BD5 0NA
Wythenshawe Hospital UHSM NHS Foundation Trust
Wythenshawe
M23 9LT
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
France, Germany, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 .
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
LFC 2012.06.01
Sponsor(s)
LifeCell
Key Dates

Recruitment Start Date

Jul 2013

Recruitment End Date

Aug 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

22 Jul 2013

Date updated in source

19 Oct 2016