NCT07678632

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2024

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 3, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2028

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

November 1, 2024

Last Update Submit

June 24, 2026

Conditions

Vascular Prosthetic Graft Infection

Keywords

Vascular Prosthetic Graft InfectionInfection PreventionHypochlorous acidWound lavage

Outcome Measures

Primary Outcomes (2)

  • Prosthetic Vascular Graft Infection

    Rate of infection as determined by Management of Aortic Graft Infection Collaboration (MAGIC) validated criteria

    12 months post surgery

  • 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.

    2 years

Secondary Outcomes (2)

  • Costs of treating Vascular Graft Infections

    2 years

  • Personal costs related to Vascular Graft infections

    2 years

Study Arms (2)

Hypochlorous acid

EXPERIMENTAL

Surgical wound lavage with hypochlorous acid after insertion of prosthetic vascular graft and prior to wound closure

Device: Hypochlorous acid

Standard of care

NO INTERVENTION

Standard of care with no surgical wound lavage

Interventions

Hypochlorous acidDEVICE

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

Hypochlorous acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Central Study Contacts

Michael C Stacey, MBBS, DS, FRACS

CONTACT

+1 905 521 2100staceymi@hhsc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Pilot randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2024

First Posted

July 1, 2026

Study Start (Estimated)

August 3, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 3, 2028

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified group data related to the two treatment arms will be available to be shared with other researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The above listed documents will be available once the study has commenced recruiting patients (currently anticipated for August 2026) and will be available until the trial has been completed and the results analyzed and published - approximately 3 years
Access Criteria
The documents listed above will be available by contacting the contact person for the study

Locations

CA(1)