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| Name | Class |
|---|---|
| University of Exeter | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSI Assisted Group | Experimental | 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. |
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| Treatment As Usual Group | No Intervention | Breast reconstruction surgery will be standard clinical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment and retention rate for both LSI-Assisted and TAU groups | Number of participants recruited to the study and number lost to follow up | End of Trial - 6 months after entry of final participant |
| Rates of post-operative complications for both LSI and TAU groups | 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. | End of Trial - 6 months after entry of final participant |
| Measure | Description | Time Frame |
|---|---|---|
| A health economic framework for the future trial. | 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. | End of Trial - 6 months after entry of final participant |
| LSI training manual and understanding the views of theatre staff on the use of LSI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucy Gates, PhD | Contact | 01392 408181 | lucy.gates1@nhs.net | |
| Angela Shore | Contact | 01392 403091 | a.c.shore@exeter.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Devon University Healthcare NHS Foundation Trust | Recruiting | Exeter | Devon | EX2 5DW | United Kingdom |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000081982 | Laser Speckle Contrast Imaging |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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. |
| End of Trial - 6 months after entry of final participant |
| Understanding the views of patients on the use of LSI. | Conduct qualitative interviews with patients in both LSI and TAU groups | End of Trial - 6 months after entry of final participant |
| LSI perfusion measures in the two groups | Assess the perfusion through the | End of Trial - 6 months after entry of final participant |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008919 |
| Investigative Techniques |