None listed
Conditions
Brief summary
This study aims to evaluate if the use of the T-stat oximeter device for breast cancer patients undergoing DIEP flap reconstruction procedures can improve post-operative sleep quality. Patients above the age of 18 year old who are diagnosed and treated for breast cancer and are about to undergo a DIEP flap reconstruction procedure are eligible for this study after appropriate consent is obtained. Participants will be randomised into either the control group or interventional group and are required to complete surveys at different timepoints of the study that evaluates sleep quality and quality of life. Control group patient will be monitored with current gold standard of care via observational and sonography ultrasounds while intervention group patients will under monitoring via the T-stat device. Results of this study aims to better future care for breast cancer patients and reduce post-operative sleep disturbance related complications.
Interventions
Intra-operative and post-operative DIEP flap continuous monitoring using the T-stat visible light spectroscopy device.
Monitoring using the T-stat device involves having the skin sensor patch stuck onto the skin of the DIEP flap (although it may be removed briefly for wound cleaning and dressing, to replace the patch, or for clinical observations or Doppler ultrasound monitoring). It will be placed on temporarily for monitoring during the operation, and constantly for 48 hours after the operat
Intra-operative and post-operative DIEP flap continuous monitoring using the T-stat visible light spectroscopy device. Monitoring using the T-stat device involves having the skin sensor patch stuck onto the skin of the DIEP flap (although it may be removed briefly for wound cleaning and dressing, to replace the patch, or for clinical observations or Doppler ultrasound monitoring). It will be placed on temporarily for monitoring during the operation, and constantly for 48 hours after the operation. Patients would be provided with an information brochure about the device and a Participant Information Sheet that will explain details about their involvement in the study. The device intervention will be performed by the research team who is also the medical care team of the participants. The team consisting of doctors and nurses will be trained (1x2hours session) prior to the study on the usage of the device by representatives of the device manufacturers, Spectros. Attendance of trained medical staff and researchers will be recorded, and only those who are trained will be involved in T-stat device manipulation during the study. Device adherence will be monitored remotely. The device is connected remotely onto an app called OnCall which the surgeons will download on their smartphones. There will not be any major operational difference due to the interventional except for the assessment of flap viability during the surgery where the interventional group will be assessed with the device placed onto the flap, while the control group will be assessed via sonography and observations.
Sponsors
Chris O'Brien Lifehouse
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient older than 18 years of age (no upper age limit) 2. Is about to undergo a DIEP flap reconstruction procedure (unilateral / bilateral) after diagnosis and treatment of breast cancer 3. Willing to provide consent and participate in the study, complying to all study requirements 4. Patients in the “learning curve” "learning curve" group is defined as the group of first few participants using the T-stat device. As the research team is using this new device for the first time and are adjusting to the usage of this device, results of these "learning curve" group may not be the optimal, but we are still including them in this study as this is a pilot study with a small sample size to test the feasibility of the device and looking at the possibility of expanding into a future large trial with a greater pool of patients.
Exclusion criteria
1. Patients who are unable to read and write in English to a level required for consent and completion of questionnaires. 2. Patient who are or potentially may be allergic to the T-stat device sensor patch. 3. Patients whose skin, due to a named or unnamed condition, presents with non-clear fluid production that may interfere with the light signal. 4. Patients who have an existing sleep disorder (e.g sleep apnoea, insomnia, parasomnias, restless leg syndrome) which can interfere with their judgement of their post-operative sleep quality. 5. Patients who have an existing mental disorder (e.g depression, anxiety) which may interfere with their ability to provide accurate responses to the SF-36 and Breast Q questionnaires.
Outcome results
None listed