Breast Reconstruction Outcomes With and without StratticE [BROWSE]
Research type
Research Study
Full title
Breast Reconstruction Outcomes With and without StratticE
IRAS ID
184887
Contact name
Claire Weston
Contact email
Sponsor organisation
LifeCell EMEA Ltd - An Acelity Company
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
Approximately 4,000 women undergo mastectomy for breast cancer each year, 1500 women have immediate breast reconstruction. Approximately half of these have implant based breast reconstruction of which many have implant assisted breast reconstruction with an acellular dermal matrix. Strattice is an acellular dermal matrix (pig skin product) made by Acelity which we use to cover and disguise the lower part of the breast implant. Acellular dermal matrices have only been used widely in the last eight years, so long-term outcomes on women who have had this form of reconstruction is minimal. Despite this it is one of the most commonly offered methods of breast reconstruction.The objective of this study is to assess the long term safety of Strattice based breast reconstruction in multiple large breast centres in the UK. This will be a case control study comparing women who have had an implant based breast reconstruction with (case) or without (control) Strattice. This will be achieved by review and analysis of retrospective data from patients who have undergone breast reconstruction using implants and Strattice™ TM in the United Kingdom and clinical assessment of their reconstruction. Outcomes including all complications, surgical re-interventions and aesthetic results will be examined and related to co-morbid conditions and other risk factors. Data will also be collected on any interventions associated with a cost, and resource utilisation.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0082
Date of REC Opinion
4 Apr 2016
REC opinion
Further Information Favourable Opinion