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.
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)
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
Factorial
Chlorhexidine mouthwash
Drug0.2% Chlorhexidine digluconate
Oxygen
DrugOxygen 80-100%
Oxygen
DrugOxygen 21-30 %
Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia (Mouthwash intervention only)
Pneumonia will be classified using the US Centers for Disease Control (CDC) definition of pneumonia
Number of participants with surgical site infection (Oxygen therapy intervention only)
The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision AND The patient must have at least one of the following: * Purulent drainage from the wound * Organisms are detected from a wound swab * Wound opened spontaneously or by a clinician AND, fever (\>38°C), OR at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; * Diagnosis of SSI by a clinician or radiological imaging
Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons)
Patient mortality status
Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only)
Repeat abdominal surgery to treat complications
Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions)
Repeat abdominal surgery
Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions)
Length of hospital stay for index admission will be collected and will measure time from surgery to time of discharge.
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