Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

PENGUIN is a pragmatic multi-center trial investigating the effects of pre-operative mouthwash and perioperative oxygen on the incidences of pneumonia and surgical site infection (SSI) following major abdominal surgery.

Patients will be recruited from low and middle income countries and randomly assigned to a trial treatment arms: a) pre-operative chlorhexidine mouthwash and 80-100% FiO2; b) no pre-operative mouthwash and 80-100% fraction of inspired oxygen (FiO2); c) pre-operative chlorhexidine mouthwash and 21- 30% FiO2; or d) no pre-operative mouthwash and 21-30% FiO2.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Birmingham
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria:

• Adults and children aged 10 years or over

• Elective or emergency abdominal surgery via midline laparotomy with an anticipated abdominal incision of at least 5cm in length

• Written informed consent of patient (signature or a fingerprint)

Exclusion Criteria:

• Patients undergoing caesarean section

• Patients with a documented or suspected allergy to chlorhexidine

• Patient unable to complete postoperative follow-up (not contactable after discharge)

• Previous enrolment in PENGUIN within the past 30 days

• American Society of Anesthesiologists (ASA) grade V patients (expected to die with or without surgery)