Does utilisation of surgical humidification reduce surgical site infection in colorectal surgery patients? A randomised control trial

Not Applicable

• Conditions: Open colorectal surgery; Wound infections; Surgical site infections; Surgery - Other surgery; Infection - Other infectious diseases

• Registration Number: ACTRN12620000269932
• Lead Sponsor: Mr Asiri Arachchi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-02
• Last Update Posted: 10 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 298

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical site infection, assessed using the Classification of Surgical Site Infections from Onyekwelu et al. (2017) adapted from the CDC/NHSN Surveillance Definitions for Specific Types of Infections[Assessment of evidence of surgical site infection at 14 days and 30 days post-operatively]