ESSBR – Effectiveness of Single Stage Breast Reconstruction
Research type
Research Study
Full title
A Prospective, Multicenter, Controlled Study of implant-based breast reconstruction, measuring the safety, effectiveness and cost consequences, of Immediate Single Stage Breast Reconstruction with Strattice™ Reconstructive Tissue Matrix versus Immediate Two Stage Breast Reconstruction without Strattice™ TM .
IRAS ID
133060
Contact name
Richard Johnson
Contact email
Sponsor organisation
LifeCell EMEA Limited
Research summary
A Prospective, Multicenter, Controlled Study of implant-based breast reconstruction, measuring the safety, effectiveness and cost consequences, of Immediate Single Stage Breast Reconstruction with Strattice™ Reconstructive Tissue Matrix versus Immediate Two Stage Breast Reconstruction without Strattice™ TM.\nThe primary objective of this study is to demonstrate the cost effectiveness 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. This is being used as a surrogate marker for cost comparison. After the study is complete the data will be used in an economic model to determine actual costs. This modeling will be performed by an independent health economics consortium.\nIn this investigation, DTI breast reconstruction will include the use of Strattice™ TM for reinforcement of tissue during surgery. With the use of Strattice™ TM in DTI reconstruction, typically less surgical procedures and hospital visits will be required to achieve final reconstruction when compared to two-stage breast reconstruction, subsequently resulting in a significantly lower overall cost.\nTwo-stage breast reconstruction will include the initial placement of a tissue expander without mesh or flap reinforcement (submuscular or dual plane). The expander will be inflated over the next one to four months, and then replaced with an implant. In two stage breast reconstruction, often multiple visits and procedures are required, thus increasing the cost of care and risks for postoperative complications for breast reconstruction.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
13/WM/0234
Date of REC Opinion
28 Jun 2013
REC opinion
Further Information Favourable Opinion