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

Condition(s) studied

Investigational drug(s) / intervention(s)

Chlorhexidine mouthwash: 0.2% Chlorhexidine digluconate

Oxygen: Oxygen 80-100%

Oxygen: Oxygen 21-30 %

Study 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.

Eligibility

Primary outcome measure(s)

• Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia (Mouthwash intervention only) — Within 30 days post-surgery from index operation
  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) — Within 30 days post-surgery from index operation
  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

Trial sites (37)

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