None listed
Conditions
Brief summary
Research Aims To assess the efficacy of warm humidified carbon dioxide (CO2) insufflation to reduce surgical site infection in patients undergoing open colorectal surgery. Participants Adult participants undergoing open colorectal surgery at Dandenong Hospital who meet the inclusion and exclusion criteria. Methods Eligible participants will be randomised to receive standard of care or standard of care plus warm humidified carbon dioxide insufflation of the open wound during their scheduled open colorectal procedure. Insufflation will be provided with the HumiGard Surgical Humidification system, up to 10L of CO2 gas will be slowly insufflated into the surgical cavity for the duration of the operation. Participants will be blinded to their allocation. Expected outcomes Completing this project will allow us to determine whether warmed and humidified carbon dioxide gas can assist with reducing surgical site infections.
Interventions
Brief name of intervention: HumiGard system
The investigational device to be used will be the Fisher and Paykel HumiGard™ Surgical Humidification System – see the user instruction provided with the humidifier (UI-185046315) during open colorectal surgery procedures (on the laparotomy wound).
The HumiGard system is a heat delivery system that allows insufflation of warm humidified CO2 into the open wound cavity. Dry medical CO2 is delivered at a flow rate of 10 L/min and a pressure of 4.5 bar f
Brief name of intervention: HumiGard system The investigational device to be used will be the Fisher and Paykel HumiGard™ Surgical Humidification System – see the user instruction provided with the humidifier (UI-185046315) during open colorectal surgery procedures (on the laparotomy wound). The HumiGard system is a heat delivery system that allows insufflation of warm humidified CO2 into the open wound cavity. Dry medical CO2 is delivered at a flow rate of 10 L/min and a pressure of 4.5 bar from a medical pressurized gas cylinder via a ¼ inch (6.35 mm) PVC tube to an open surgery humidification system (F&P HumiGard™, Fisher & Paykel Healthcare Ltd, Auckland, New Zealand). It consists of a bacterial filter, and a humidification chamber filled with 180 ml sterile water, positioned on a humidifier controller that includes an integrated temperature and flow sensor. The outlet of the humidification chamber is connected to a thermally insulated 2.5 m long heated insufflation tube that maintains temperature and humidity of the gas to its outlet. The humidified and warm CO2 enters a gas diffuser (VITA-diffuser®, Cardia Innovation AB, Stockholm, Sweden) consisting of a 25 cm long PVC tube (inner diameter of 2.5mm) with polyurethane foam at its end. The cylindrical polyurethane foam tip diverts the gas jet into multiple directions via the many small paths inside the foam. The gas is thus uniformly distributed and the large diffuser surface area greatly reduces the velocity of the outflow. Participants that are included will be randomly allocated, 1:1, to one of two groups (n = 149 per group); HumiGard™ (intervention) standard of care (no intervention) in elective and emergency open colorectal surgery cases. The intervention will be delivered by surgeons and theatre staff (trained to use the device on open colorectal surgery laparotomy wounds) to patients in person, individually to each patient, during their open colorectal surgery procedure only, with the surgery performed in a hospital. It is a standardised intervention that will not be personalised, titrated or adapted to individuals or groups of individuals in the intervention arm. em intervention during their open colorectal surgery procedure (i.e. no additional treatment). Standard of care will be otherwise followed as routine at our institution for patients undergoing open colorectal surgery procedures.
Sponsors
Mr Asiri Arachchi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing elective or emergency open colorectal resection 2. Able to give informed consent
Exclusion criteria
1. Pregnancy 2. Terminal organ impairment 3. Patients that have to return to theatre for pathology unrelated to surgical wound site infection such as anastomotic leaks, revisions or re-look laparotomy washouts 4. Evidence, preoperatively, of any of the following: sepsis, severe sepsis, or septic shock 5. Contraindication for CO2 6. BMI > 40 as patients with morbid obesity will have higher mortality and SSI rates 7. Current abdominal wall infection/surgical site infection secondary to previous laparotomy/laparoscopy or from any other cause 8. History of laparotomy within the last 60 days 9. Immunological disease (e.g. HIV/AIDS) 10. Systemic steroid use or other immunosuppressant medication 11. ASA score greater than or equal to 4 12. Uncontrolled diabetes mellitus 13. Use of wound protection devices such as the Alexis port
Outcome results
None listed