Adiposet Fat Grafting (AFG001)
Research type
Research Study
Full title
Healthcare evaluation of cost-effectiveness and PROMs of Adiposet fat storage system versus standard care for fat grafting procedure in breast reconstruction
IRAS ID
252571
Contact name
R D Macmillan
Contact email
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This study will assess pain, quality of life and function following a breast reconstruction procedure(s) called fat grafting versus fat storage fat grafting procedure(s). In addition, the study aims to understand the costs associated with repeated individual fat grafting procedures versus fat storage procedures. To date there has been minimal research into patient reported outcomes following fat grafting surgery or health economic analysis reported.
Women who are over 18; are a patient of the Nottingham Breast Institute; have a planned single fat grafting procedure or serial fat grafting procedures and are able to consent to surgery themselves are eligible to take part in this study at the Nottingham University Hospitals NHS Trust.
Fat grafting requires fat to be harvested from other parts of the body, usually the thighs, stomach, and buttocks, by liposuction. The tissue is then processed into liquid and injected into the breast area to reconstruct the breast within the same surgery. The fat grafting surgery (harvest and re-injection) is undertaken using general anaesthetic. Women who undergo fat grafting may need more than one procedure (serial fat grafting) to achieve the desired result and to compensate for some fat re absorption. Each individual fat grating procedure carries the same post-operative bruising and pain risks.
The Adiposet fat storage system is not being tested, it is available to the NHS and is being used by other Trusts but not currently used in local practice due to lack of information regarding cost and patient reported benefit compared to current standard care. The system is for women who are identified as potentially needing serial fat grafting. They could have a larger fat harvest in the first procedure and then have the fat stored in a regulated biobank for injection at a later date.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
19/YH/0070
Date of REC Opinion
22 Mar 2019
REC opinion
Further Information Favourable Opinion