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Trial Title:
Laser Speckle Imaging During Breast Reconstruction
NCT ID:
NCT06523452
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Laser Speckle Imaging
Description:
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.
Arm group label:
LSI Assisted Group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Royal Devon University Healthcare NHS Foundation Trust
Address:
City:
Exeter
Zip:
EX2 5DW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Lucy Gates
Phone:
01392 408181
Email:
lucy.gates1@nhs.net
Contact backup:
Last name:
Angela Shore
Phone:
01392403091
Email:
a.c.shore@exeter.ac.uk
Investigator:
Last name:
Andrew Wilson
Email:
Principal Investigator
Start date:
April 25, 2024
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Royal Devon and Exeter NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
University of Exeter
Agency class:
Other
Source:
Royal Devon and Exeter NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06523452
