SIMBAR
Research type
Research Study
Full title
The clinical and cost effectiveness of intra-operative Laser Speckle Imaging (LSI) of tissue blood flow to avoid post-operative complications following breast reconstruction after mastectomy for breast cancer: A feasibility study.
IRAS ID
331259
Contact name
Andrew Wilson
Contact email
Sponsor organisation
Royal Devon University Healthcare NHS Foundation Trust
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Around 3500 women a year have surgery to reconstruct a breast/s after cancer. Breast reconstruction can have a positive impact on their lives, but unfortunately 3 or 4 in 10 women have problems with healing after their operation. This is distressing and often leads to more medical care or surgery. These problems are often caused by poor blood flow to the skin and deeper tissues used to reconstruct the breast. We have developed a new device that does not touch the skin and provides immediate, continuous images of skin blood flow (the flow that surgeons cannot see). To test this device we took images of blood flow during breast reconstruction surgery. We found that imaging was good at showing where skin blood flow was poor and led to problems with healing and where flow was good and there were fewer problems after surgery (from minor problems, e.g. delayed healing; to major problems, e.g. loss of new breast). We think this device can help surgeons choose healthy skin during breast reconstruction and so help more patients to heal without surgical problems. We need to test the new imaging device in a large clinical trial to find out how effective it is at improving healing for women after breast reconstruction. Before this, we need to find out if such a trial is possible and acceptable to patients, theatre staff and surgeons. Across three hospitals (Exeter, Portsmouth and East Grinstead) we will recruit 60 women who are having breast surgery; we will randomly choose 30 to have surgery without blood flow imaging and 30 to have surgery with blood flow imaging. We will follow up the women whilst in hospital and for the following 6 months to record any problems. In particular we need to find out how many patients will volunteer for the study and if we can collect all the information we need during the 6 months after surgery. The results from this study will be used to plan a much larger clinical trial that will test whether blood flow imaging is effective, improves patient recovery after surgery and provides good value for money for the NHS.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0045
Date of REC Opinion
27 Feb 2024
REC opinion
Favourable Opinion