This is a study of the use of an antibacterial solution, Hypochlorous acid, to prevent infection in vascular surgery bypass grafts. The solution will be used at the end of operations to insert a prosthetic vascular surgery bypass graft, to wash the wound and the vascular bypass graft before the wound is closed. The patients in this study will be undergoing surgery for problems with narrowed and or blocked arteries. The presence or absence of a graft infection will be followed for 12 months following the surgery. Prosthetic vascular graft infections have significant implications for patients with high rates of death and amputation, hence preventing them will have significant benefits for patients and the health care system.
Patients undergoing elective or emergent open insertion of prosthetic vascular grafts to the abdominal and/or lower limb vessels, including all prosthetic bypass grafts and patch grafts
Patients 18 years of age or older
Able to provide informed consent in English
Patients undergoing vascular surgery that does not involve the insertion of a prosthetic graft to the abdominal and/or lower limb vessels by an open operation
Patients under the age of 18 years
Patients who are unable to provide informed consent in English
Parallel
Hypochlorous acid
DeviceSolution of hypochlorous acid - 500m l per wound site to be used to lavage the wound
Prosthetic Vascular Graft Infection
Rate of infection as determined by Management of Aortic Graft Infection Collaboration (MAGIC) validated criteria
Feasibility of full Randomized Controlled trial
Assess the feasibility of conducting a full randomized controlled trial, based on the Vascular Graft Infection rates in the hypochlorous arm and the standard of care arm of the study, and a subsequent sample size analysis which will determine the number of patients needed to successfully conduct such a study.
Costs of treating Vascular Graft Infections
That added costs of treating Vascular Graft infections related to additional hospitalizations will be captured in order to determine the benefits associated with reducing vascular graft infections.
Personal costs related to Vascular Graft infections
The personal cost to patients will also be captured in relation to additional travel, loss of income, additional care at home and costs related to relocating residence if necessary.
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Hamilton Health Sciences Corporation
Lead sponsor
McMaster University
Collaborator
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