A Phase 3 interventional study of Chlorhexidine mouthwash and Oxygen in Infection, Pneumonia and Surgical Site Infection, sponsored by University of Birmingham. Recruiting at 37 sites in 5 countries. Open to participants aged 10 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by University of Birmingham · Phase 3, Interventional, and Treatment
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.
PENGUIN is a pragmatic, blinded (outcome assessor), 2x2 factorial, multi-centre randomised controlled trial, with an internal pilot, to evaluate measures to reduce surgical site infection (SSI) and pneumonia rates in patients undergoing surgery with an abdominal incision.
Pneumonia is one of the most serious complications to occur after surgery, accounting for up to one in four of all postoperative deaths. The incidence is greater still in high-risk populations such as those undergoing midline laparotomy where mortality rates are more than 10%. SSIs are clearly important being the most frequent healthcare-associated infection in LMICs, affecting one in three patients undergoing contaminated or dirty surgery (34, 35). SSIs cause pain, discomfort and disability. They increase the time taken to return to work, and healthcare costs
The risk of postoperative mortality and complications such as surgical site infection is three times greater in low and middle-income countries (LMICs) than in high-income countries. In order to address surgical need worldwide, it is estimated that provision of a further 312 million operations would be required each year.
Patients will be recruited from hospitals in Low and Middle Income Countries (LMICs) who are undergoing elective or emergency mid-line laparotomy. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between:
A. Preoperative chlorhexidine mouthwash and 80-100% FiO2 during surgery B. No preoperative chlorhexidine mouthwash and 80-100% FiO2 during surgery C. Preoperative chlorhexidine mouthwash and 21-30% FiO2 during surgery D. No preoperative chlorhexidine mouthwash and 21-30% FiO2 during surgery
The 6 month internal pilot will assess the feasibility of recruitment, compliance with treatment allocation and patient retention and follow-up rates. The main Randomised Control Trial will recruit 12,924 participants.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 12,942 is above the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 80-100% FiO2 during surgery.
Drug: Chlorhexidine mouthwash · Drug: Oxygen
No pre-surgical mouthwash in combination with 80-100% FiO2 during surgery.
Drug: Oxygen
Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 21-30% FiO2 during surgery.
Drug: Chlorhexidine mouthwash · Drug: Oxygen
No pre-surgical mouthwash in combination with 21-30% FiO2 during surgery.
Drug: Oxygen
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
Time frame: Within 30 days post-surgery from index operation
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
Time frame: Within 30 days post-surgery from index operation
Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons)
Patient mortality status
Time frame: Within 30 days post-surgery from index operation
Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only)
Repeat abdominal surgery to treat complications
Time frame: Within 30 days post-surgery from index operation
Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions)
Repeat abdominal surgery
Time frame: Within 30 days post-surgery from index operation
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.
Time frame: Within 30-days post surgery from index operation
Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions)
Return to normal activities (e.g. work, school, or family duties) ascertained by trial specific case report forms.
Time frame: Within 30 days post-surgery from index operation
Number of participants admissions to a critical care unit (Mouthwash and oxygen therapy interventions)
Admission to a critical care unit will be captured on the trial case report forms.
Time frame: Within 30 days post-surgery from index operation
Health resource usage per patient
Resource use data will be collected as part of the economic evaluation of the different treatment combinations in a sub-group of adult patients at selected centers. Information related to post-operative cost (medicinal products, amenities and personal) will be collected on a health resource usage case report form designed by the trials health economist.
Time frame: Within 30 days post-surgery from index operation
Plan to share: Yes — Data will be shared via a process of controlled access
Supporting information: Study protocol, Informed consent form
Time frame: 6 months post publication
Access criteria: Formal requests must be submitted to the Data Access Group at Birmingham Clinical Trials Unit
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Studies of the drug tested here: Chlorhexidine