Prevention of Vascular Graft Infection With Hypochlorous Acid

Condition(s) studied

Investigational drug(s) / intervention(s)

Hypochlorous acid: Solution of hypochlorous acid - 500m l per wound site to be used to lavage the wound

Study summary

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.

Eligibility

Primary outcome measure(s)

• Prosthetic Vascular Graft Infection — 12 months post surgery
  Rate of infection as determined by Management of Aortic Graft Infection Collaboration (MAGIC) validated criteria
• Feasibility of full Randomized Controlled trial — 2 years
  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.

Trial sites (1)

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