2 Ethics ref: 15/NTA/66 Title: Effect of warm humidified carbon dioxide on bacteria in a surgical wound Principal Investigator: Mrs Jessica Fogarin Sponsor: Fisher & Paykel Healthcare Clock Start Date: 28 May 2015 Mrs Jessica Fogarin was present by teleconference for discussion of this application. Potential conflicts of interest The asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee queried how the DSMC will work noting the CI is the data monitor. Mrs Fogarin explained that this conflict was raised trial to the HDEC meeting and had subsequently been changed. Monitoring arrangements will be passed from CI to the other colleagues. This measure mitigates the conflict bias. The Committee asked if this (warm humidified carbon dioxide) was standard treatment. Mrs Fogarin explained it was not standard of care at Auckland Hospital. It is available commercially for purchase and is used internationally. It is also used at Waikato Hospital. It is just not used in Auckland. What is the reason for the study? Mrs Fogarin explained the study investigates the impact of this system specifically on bacterial load. The current benefit is due to reducing heat loss - that is the benefit of using this system however it remains unclear whether the application of CO2 impacts the number of bacteria in the wound. The Committee requested justification of blinding patients. Mrs Fogarin explained there are a number of observations that are taken the day post healing - they don’t want the participants to be biased about how they treat or describe their own wound. Please explain how safety is monitored, who will install the device? The CI will set up and install the device. The surgeon and anesthetist will be involved in terms of putting the device in the participant. Mrs Fogarin confirmed that the surgeon, Mr John Windsor, is an investigator. Will the surgeon be the same for all participants? Mrs Fogarin stated yes, only 10 participants. What are the criteria for stopping the particularly with respect to safety? Mrs Fogarin stated there are no known side effects or safety issues. The system is standard practice at many other sites and widely used internationally. It will be at the discretion of the surgeon to stop the use of this device for any clinical reason.
2 Ethics ref: 15/NTA/66 Title: Effect of warm humidified carbon dioxide on bacteria in a surgical wound Principal Investigator: Mrs Jessica Fogarin Sponsor: Fisher & Paykel Healthcare Clock Start Date: 28 May 2015 Mrs Jessica Fogarin was present by teleconference for discussion of this application. Potential conflicts of interest The asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee queried how the DSMC will work noting the CI is the data monitor. Mrs Fogarin explained that this conflict was raised to the HDEC meeting and had subsequently been changed. Monitoring arrangements will be passed from CI to the other colleagues. This measure mitigates the conflict bias. The Committee asked if this (warm humidified carbon dioxide) was standard treatment. Mrs Fogarin explained it was not standard of care at Auckland Hospital. It is available commercially for purchase and is used internationally. It is also used at Waikato Hospital. It is just not used in Auckland. What is the reason for the study? Mrs Fogarin explained the study investigates the impact of this system specifically on bacterial load. The current benefit is due to reducing heat loss - that is the benefit of using this system however it remains unclear whether the application of CO2 impacts the number of bacteria in the wound. The Committee requested justification of blinding patients. Mrs Fogarin explained there are a number of observations that are taken the day post healing - they don’t want the participants to be biased about how they treat or describe their own wound. Please explain how safety is monitored, who will install the device? The CI will set up and install the device. The surgeon and anesthetist will be involved in terms of putting the device in the participant. Mrs Fogarin confirmed that the surgeon, Mr John Windsor, is an investigator. Will the surgeon be the same for all participants? Mrs Fogarin stated yes, only 10 participants. What are the criteria for stopping the particularly with respect to safety? Mrs Fogarin stated there are no known side effects or safety issues. The system is standard practice at many other sites and widely used internationally. It will be at the discretion of the surgeon to stop the use of this device for any clinical reason. trial