RecruitingACTRN12617001558314

Effect of warm humidified insufflated carbon dioxide on wound bacterial load in open elective gastrointestinal surgery: a pilot investigation.


Sponsor

Fisher and Paykel Healthcare

Enrollment

10 participants

Start Date

Jan 25, 2018

Study Type

Interventional

Conditions

Summary

Surgical site infection (SSI) is an infection which can develop in the wound created by a surgical procedure. SSI is a potential side effect of any surgical procedure. The purpose of this investigation is to provide data for helping design a larger controlled study which will investigate whether blowing warm, humidified carbon dioxide (CO2) into the surgical cavity during surgery can reduce the number of bacteria in the surgical wound, potentially reducing the risk of SSI. We are also interested in how the gas treatment alters the way your skin wound edge responds and heals. It is possible that the gas may improve the healing process after surgery. Participants undergoing elective gastrointestinal surgery at Auckland City Hospital who meet the inclusion and exclusion criteria will be offered the opportunity to participate in the pilot study. If patients meet the above criteria and choose to take part in the study, they will be randomised (selected by chance by a computer) to receive the CO2 treatment or standard care (no CO2). If randomised into the CO2 treatment group, warm humidified CO2 gas will be slowly insufflated (blown) into the abdominal cavity during the planned surgery. The CO2 gas is delivered by a small, flexible, non-invasive tube which is placed inside the surgical wound during the operation. This trial will take 30 days to complete, not including an initial assessment to check if the patient meets the inclusion and exclusion criteria. There will be 4 scheduled assessments. These assessments will be undertaken during the standard routine check-up expected after surgery so will not take any additional time. Assessments will be made at the following time points. Day 1 (surgery), Day 5 (in-patient), Discharge, Day 30 Follow-Up Visit. To measure the number of bacteria in the wound, a swab will be taken by gently wiping the edge of the wound of all participants. Samples will be taken by the surgeon while the patient is under an anesthesia at the beginning of the surgery; 1 hour into the procedure; 2 hours into the procedure; and at the end of the surgery before the surgical wound is closed. In addition two sets of two small biopsies (small samples of your skin wound) during the operation will be taken. These biopsies are taken while the patient is under anesthesia from along the skin edges that are already part of the main operation wound. They will be inside the area of the main operation wound and will not make the scar any longer. On Day 5, the surgical dressing will be removed at 48hrs post-surgery, and the wound will be reviewed by a nurse to check for any potential SSI. At discharge the surgical wound will be reviewed by a nurse to check for any potential SSI. The patient will be contacted again at 30 days to discuss any SSI have developed.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether blowing warm, moist carbon dioxide (CO2) gas into the surgical wound during abdominal surgery can reduce the number of bacteria in the wound and lower the risk of post-surgical infection. Participants are randomly assigned to receive CO2 gas during their operation or to have standard surgery without CO2. You may be eligible if: - You are aged 18 to 65 - You are scheduled for an open abdominal (gastrointestinal) surgery expected to last more than 120 minutes - Your HbA1c (blood sugar control measure) is below 49 mmol/mol - You are able to give informed consent You may NOT be eligible if: - You have signs of sepsis or serious infection before surgery - Your BMI is above 30 - You have had a previous abdominal surgery within the past 60 days - You have an immune system condition (e.g. HIV) or are on immunosuppressant drugs - You currently smoke or are unwilling to stop smoking 30 days before surgery - You have uncontrolled diabetes Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will be randomly allocated to receive CO2 insufflation during their surgical procedure or standard care (Surgery without any additional intervention). The CO2 will be delivered into the open

Patients will be randomly allocated to receive CO2 insufflation during their surgical procedure or standard care (Surgery without any additional intervention). The CO2 will be delivered into the open peritoneal cavity by the Fisher and Pykel HumigardTM surgical humidification system throughout the duration of the surgery (from incision to surgical close). The HumigardTM surgical humidification system creates a local atmosphere of CO2 heated to 37oC at 100% relative humidity which is thought to decrease airborne contamination, reduce bacterial growth and decreased heat loss during surgery. Intervention arm - Consented patients undergoing Whipples procedure at Auckland City Hospital will receive insufflated CO2 in the surgical wound throughout the procedure. The Humigard TM device will be set up and operated by the consultant surgeon and the surgical team in the operating theatre. Swabs will be taken at time of incision, 1 hour, 2 hours and at surgical wound close. These swabs will be analysed for bacterial growth and compared against the patients how did not receive CO2. At time of incision and closure, 2 6mm skin biopsies will be taken along the incision line. This is to determine wound edge tissue response. A research nurse will be present throughout the procedure and will assist in sample collection and Humigard maintenance. All patients will be followed by a research nurse at 30 days over the phone to assess if there has been any surgical site infection.


Locations(1)

Auckland, New Zealand

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ACTRN12617001558314


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