Prevena evaluation in therapeutic mammoplasty
Research type
Research Study
Full title
The role of PREVENA vacuum dressings in patients undergoing bilateral mammoplasty surgery
IRAS ID
254703
Contact name
Andrew Pieri
Contact email
Sponsor organisation
Newcastle Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN30055885
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A therapeutic mammoplasty is a procedure where a breast reduction is performed in order to remove a breast cancer. At our institute, it is normal practice to also perform the same breast reduction procedure on the opposite breast at the same time in order to maintain symmetry. This operation has a relatively high risk of wound complications (around 20%).
Recently a negative pressure dressing called Prevena has become available and has been demonstrated to reduce wound complication rates by up to 4-fold in other types of surgery (abdominal, vascular, orthopaedic uses). There is currently no evidence for Prevena dressing use in breast surgery.
We aim to perform a randomised control trial for patients undergoing bilateral mammoplasty surgery, using a Prevena dressing on one side and a conventional dressing on the other. Patients will undergo wound assessment at 1, 2 and 6 weeks post-operatively to assess the difference in wound complication rates between Prevena and conventional dressings.
The study will be performed at a single centre (RVI, Newcastle Upon Tyne) and will require approximately two years to recruit a sufficient number of patients.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0069
Date of REC Opinion
30 Apr 2019
REC opinion
Further Information Favourable Opinion