Laser Speckle Imaging During Breast Reconstruction

NCT06523452 — Not applicable, Unknown, 60 participants, Royal Devon and Exeter NHS Foundation Trust

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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

Registry	NCT06523452, acronym SIMBAR
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, other
Enrollment	60 (Estimated)
Sponsor	Royal Devon and Exeter NHS Foundation Trust (Other); collaborators: University of Exeter
Conditions	Breast Cancer
Interventions	Laser Speckle Imaging (Other)
Dates	start 2024-04-25, primary completion 2025-05-01 (estimated), completion 2025-05-01 (estimated), first posted 2024-07-26, last updated 2024-07-26
Locations	1 site in 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.

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+Arms and interventions

Arm	Type	Interventions	Description
LSI Assisted Group	Experimental	Other: Laser Speckle Imaging	Breast reconstruction surgery will be standard clinical care, but tissue blood flow images will be available during surgery to aid surgical decision making. The surgical procedure will take slightly longer (approximately 10-15 minutes in total) compared to the Treatment As Usual group.
Treatment As Usual Group	No intervention		Breast reconstruction surgery will be standard clinical care

Laser Speckle Imaging (Other): At least three scans (four for skin sparing mastectomy) will be performed on participants randomised to the LSI Assisted Group. Further scans may be taken at the discretion of the surgeon.

+Outcome measures

Primary outcomes

Recruitment and retention rate for both LSI-Assisted and TAU groups [End of Trial - 6 months after entry of final participant]: Number of participants recruited to the study and number lost to follow up
Rates of post-operative complications for both LSI and TAU groups [End of Trial - 6 months after entry of final participant]: 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.

Secondary outcomes

A health economic framework for the future trial. [End of Trial - 6 months after entry of final participant]: 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.
LSI training manual and understanding the views of theatre staff on the use of LSI. [End of Trial - 6 months after entry of final participant]: 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.
Understanding the views of patients on the use of LSI. [End of Trial - 6 months after entry of final participant]: Conduct qualitative interviews with patients in both LSI and TAU groups
LSI perfusion measures in the two groups [End of Trial - 6 months after entry of final participant]: Assess the perfusion through the

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Royal Devon University Healthcare NHS Foundation Trust	Exeter, Devon	United Kingdom	Recruiting