Capsule study
Research type
Research Study
Full title
A study investigating the mechanisms associated with capsule formation in patients undergoing breast reconstruction with implant and acellular dermal matrix (ADM)
IRAS ID
206385
Contact name
Cliona Kirwan
Contact email
Sponsor organisation
University Hospital of South Manchester
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
Over the past 15 years there has been almost a 50% increase in the number of women undergoing immediate breast reconstruction after mastectomy for the treatment of breast cancer in the UK. In 2012 16430 immediate breast reconstructions were performed. More than 85% of these were implant based breast reconstruction of which many have implant assisted breast reconstruction with an acellular dermal matrix. Strattice is an acellular dermal matrix (ADM), pig skin product, made by Acelity which we use to cover and disguise the lower part of the breast implant. Implant-based reconstruction is particularly prone to the development of capsular contracture, which is excessive formation of scar tissue around the implant that results in poor cosmesis and pain. ADMs are reported to be associated with reduced capsular contracture. The objective of this study is to determine molecular mechanisms associated with capsule formation around breast silicone implants compared to around ADMs. This will be achieved by taking four biopsies from the capsule in women undergoing revisional surgery following implant-ADM reconstruction. Two at the site of the previous ADM placement and two away from it. These biopsies will undergo laboratory testing and results compared ADM site vs. non-ADM site and with the clinical assessment of the patient.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0373
Date of REC Opinion
14 Jun 2016
REC opinion
Further Information Favourable Opinion