Clinical trial NCT06523452: Laser Speckle Imaging During Breast Reconstruction
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Exeter
First posted: 2024-07-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Female, aged 18 or over;
* Able and willing to provide informed consent;
* Scheduled for breast reconstruction by autologous free flap surgery (either immediately post-mastectomy or delayed).

Exclusion Criteria:

* Unable to give written informed consent.

Primary outcomes:
measure: Recruitment and retention rate for both LSI-Assisted and TAU groups
timeFrame: End of Trial - 6 months after entry of final participant
measure: Rates of post-operative complications for both LSI and TAU groups
timeFrame: End of Trial - 6 months after entry of final participant
Secondary outcomes:
measure: A health economic framework for the future trial.
timeFrame: End of Trial - 6 months after entry of final participant
measure: LSI training manual and understanding the views of theatre staff on the use of LSI.
timeFrame: End of Trial - 6 months after entry of final participant
measure: Understanding the views of patients on the use of LSI.
timeFrame: End of Trial - 6 months after entry of final participant
measure: LSI perfusion measures in the two groups
timeFrame: End of Trial - 6 months after entry of final participant
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon University Healthcare NHS Foundation Trust
state: Devon
Study officials:
References: