Laser Speckle Imaging During Breast Reconstruction
NCT Number: NCT06523452
Acronym: SIMBAR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: OTHER: Laser Speckle Imaging
Sponsor: Royal Devon and Exeter NHS Foundation Trust
Collaborators: University of Exeter
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-04-25
Completion Date: 2025-05-01
Locations: Royal Devon University Healthcare NHS Foundation Trust, Exeter, Devon, EX2 5DW, United Kingdom

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. The investigators 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 the investigators took images of blood flow during breast reconstruction surgery. The investigators 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).

The investigators think this device can help surgeons choose healthy skin during breast reconstruction and so help more patients to heal without surgical problems. The investigators 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, the investigators need to find out if such a trial is possible and acceptable to patients, theatre staff and surgeons. The investigators will recruit 60 women who are having breast surgery and will randomly choose 30 to have surgery without blood flow imaging and 30 to have surgery with blood flow imaging. The investigators will follow up the women whilst in hospital and for the following 6 months to record any problems. In particular the investigators need to find out how many patients will volunteer for the study and the study can collect all the information needed 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.

Primary Outcome Measures: Recruitment and retention rate for both LSI-Assisted and TAU groups, Number of participants recruited to the study and number lost to follow up, End of Trial - 6 months after entry of final participant|Rates of post-operative complications for both LSI and TAU groups, Number of participants with post-operative complications and their severity over 6 months post operative using patient diaries and patient notes assessed by Clavien-Dindo or CTCAE., End of Trial - 6 months after entry of final participant
Secondary Outcome Measures: A health economic framework for the future trial., Economic evaluation methods will be developed and tested on the collection of resource use, cost and QoL outcome data assessed using Resource Use, EQ-5D-5L and BREAST Q questionnaires., End of Trial - 6 months after entry of final participant|LSI training manual and understanding the views of theatre staff on the use of LSI., Develop appropriate training material for use of LSI Device through conducting pre-operative observations, focus groups and post operative interviews with theatre staff to assess feasibility and acceptability of LSI., End of Trial - 6 months after entry of final participant|Understanding the views of patients on the use of LSI., Conduct qualitative interviews with patients in both LSI and TAU groups, End of Trial - 6 months after entry of final participant|LSI perfusion measures in the two groups, Assess the perfusion through the, End of Trial - 6 months after entry of final participant