ADM Strattice Breast Trial
Research type
Research Study
Full title
Immediate Breast Reconstruction with or without the use of Acellular Dermal Matrix (Strattice™)-A Randomized Controlled Trial
IRAS ID
150240
Contact name
Pankaj Roy
Contact email
Sponsor organisation
Karolinska University Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This randomized controlled multicentre trial aims to evaluate the effectiveness of using Acellular Dermal Matrix (Strattice™) in post-mastectomy Immediate Breast Reconstruction (IBR) with implants, in the setting of breast cancer treatment. The study aims to recruit 120 patients over 3 years at 5 centres across the UK and Sweden.
Currently in Oxford, most patients receiving Immediate Breast Reconstruction (IBR) using implants will undergo a two stage post-mastectomy reconstruction involving an initial procedure to fit a tissue expander and then a second surgery to replace the tissue expander with a permanent breast implant. This study will compare this standard treatment option with the additional use of ADM (Strattice™) as a surgical mesh reinforcement.
The study will evaluate the two treatment arms in terms of effectiveness, safety and efficacy endpoints as well as economic considerations. The primary outcome measure is a comparison of the number of unplanned/unanticipated surgical breast surgeries after treatment. Secondary outcome measures include complication rates, aesthetic outcome, quality of life and cost-benefit analysis.
Strattice™ is currently not available for patients undergoing treatment for breast cancer in OUH trust due to cost. The results of this study may support a case for the routine use of the product at the OUH Trust if the cost of the product is offset by the reduction in number of subsequent operations or reduced hospital visits.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0123
Date of REC Opinion
26 Apr 2016
REC opinion
Further Information Favourable Opinion