Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523452
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-12
Brief Title:
Laser Speckle Imaging During Breast Reconstruction
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMBAR
Brief Summary:
Around 3500 women a year have surgery to reconstruct a breasts 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 eg delayed healing to major problems eg 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None