None listed
Conditions
Brief summary
The VIBE study aims to investigate the effect of Voyant Versus Diathermy for Haemostasis on post-surgical drainage and seroma in Breast Cancer Surgery Who is it for? You may be eligible to join this study if you are aged 18 years or above, diagnosed with breast cancer and undergoing unilateral or bilateral mastectomy Study details Participants in this study will randomly be allocated (by chance) to one of two groups: one group will be allocated the Voyant™ Intelligent Energy System for tissue dissection and vessel sealing during surgery while the other group will be allocated standard surgical care with conventional diathermy for tissue dissection and vessel sealing during surgery. Outcomes assessed up to 30 days post-surgery include time to drain removal, total drain output, seroma, and other recovery measures such as pain, complications, and quality of life. This research may help identify the most effective surgical device for reducing post-operative drainage and seroma after breast cancer surgery, with the potential to improve recovery and patient outcomes.
Interventions
Arm A: Voyant Intelligent Energy System
Participants in this arm will undergo planned breast surgery using the Voyant Intelligent Energy System for tissue dissection, haemostasis and vessel sealing during the main operative phase of surgery. Voyant is an advanced bipolar energy device that differs from standard care diathermy by using controlled bipolar energy designed for vessel sealing and tissue division rather than conventional monopolar or bipolar electrosurgery alone. The procedure duratio
Arm A: Voyant Intelligent Energy System Participants in this arm will undergo planned breast surgery using the Voyant Intelligent Energy System for tissue dissection, haemostasis and vessel sealing during the main operative phase of surgery. Voyant is an advanced bipolar energy device that differs from standard care diathermy by using controlled bipolar energy designed for vessel sealing and tissue division rather than conventional monopolar or bipolar electrosurgery alone. The procedure duration is expected to be approximately 1–3 hours, depending on the type and extent of surgery. The intervention will be delivered by the treating breast surgeon and/or appropriately trained surgical team members. Adherence will be monitored through operation notes, theatre documentation and study case report forms recording the device used.
Sponsors
Calvary Mater Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults greater or equal to 18 years of age Undergoing unilateral or bilateral mastectomy Able to provide informed consent
Exclusion criteria
Simultaneous major reconstructive procedures (e.g. free flap) Prior ipsilateral axillary surgery Known bleeding disorders or contraindications to stopping anticoagulation Active infection or pregnancy
Outcome results
None listed