At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Laser Speckle Imaging (other)
- How long the study runs
- Study runs about 13 months (dates as stated)
- About the drug or intervention
- Laser Speckle Imaging — other: At least three scans (four for skin sparing mastectomy) will be performed on participants randomised to the LSI Assisted Group.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 60
- Started
- 2024-04-25
- Last checked
- 2024-06
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • NA - 60 participants
- • Around 3500 women a year have surgery to reconstruct a breast/s after cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast cancer
- • Female only
Where?
- • Exeter - Royal Devon University Healthcare NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
What the study is looking for
- ✓Female, aged 18 or over;
- ✓Able and willing to provide agreement to take part;
- ✓Scheduled for breast reconstruction by autologous free flap surgery (either immediately post-mastectomy or delayed).
Who cannot take part
- ✗Unable to give written agreement to take part.
See the full criteria
Where Is This Study? (1 UK site)
Royal Devon University Healthcare NHS Foundation Trust
Exeter EX2 5DW, United Kingdom
How to Get in Touch
Lucy Gates, PhD
Sponsor contactCONTACT
Angela Shore
Sponsor contactCONTACT