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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mouthwash and liberal oxygen during surgery | Experimental | Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 80-100% FiO2 during surgery. |
|
| No mouthwash and liberal oxygen during surgery | Active Comparator | No pre-surgical mouthwash in combination with 80-100% FiO2 during surgery. |
|
| Mouthwash and restrictive oxygen during surgery | Experimental | Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 21-30% FiO2 during surgery. |
|
| No mouthwash and restrictive oxygen during surgery | Active Comparator | No pre-surgical mouthwash in combination with 21-30% FiO2 during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine mouthwash | Drug | 0.2% Chlorhexidine digluconate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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:
| Within 30 days post-surgery from index operation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons) | Patient mortality status | Within 30 days post-surgery from index operation |
| Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Divya Kapoor | Contact | 01214159127 | penguin@trials.bham.ac.uk | |
| Rachel Lillywhite, BA | Contact | 01214159127 | penguin@trials.bham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Rupert Pearse | Royal London Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina de Botucatu - UNESP | Recruiting | Botucatu | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40255646 | Derived | PENGUIN Trial Management Groupj.glasbey@bham.ac.uk23cgeorge@gmail.com; NIHR Global Health Research Unit on Global Surgery Collaborators; PENGUIN Trial Management Group. PErioperative respiratory care aNd outcomes for patients underGoing hIgh risk abdomiNal surgery (PENGUIN): a randomised international internal pilot trial. BJA Open. 2025 Apr 10;14:100396. doi: 10.1016/j.bjao.2025.100396. eCollection 2025 Jun. |
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Data will be shared via a process of controlled access
6 months post publication
Formal requests must be submitted to the Data Access Group at Birmingham Clinical Trials Unit
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| Oxygen | Drug | Oxygen 80-100% |
|
| Oxygen | Drug | Oxygen 21-30 % |
|
Repeat abdominal surgery to treat complications |
| Within 30 days post-surgery from index operation |
| Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions) | Repeat abdominal surgery | 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. | 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. | 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. | 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. | Within 30 days post-surgery from index operation |
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | Brazil |
|
| Hospital Nossa Senhora da Conceicao | Recruiting | Porto Alegre | Brazil |
|
| Hospital Universitario Professor Edgar Santos/Bahia | Recruiting | Salvador | Brazil |
|
| Hospital Sao Jose - Criciuma/SC | Recruiting | São José | Brazil |
|
| Homi Bhabha Cancer Hospital & Research Centre | Recruiting | Visakhapatnam | Andhra Pradesh | 530053 | India |
| Sher - i - Kashmir Institute of Medical Sciences | Recruiting | Srinagar | Jammu and Kashmir | 190011 | India |
| Chinchpada Christian Hospital | Recruiting | Chinchpāda | Maharashtra | 425417 | India |
| Kasturba Medical College Hospital, Manipal | Recruiting | Madhava Nagar | Manipal, Karnataka | 576104 | India |
| Government Medical College, Patiala | Recruiting | Patiāla | Punjab | 147001 | India |
| All India Institute of Medical Sciences, Bhubaneswar | Recruiting | Bhubaneswar | 751019 | India |
| Government Medial College & Hospital, Chandigarh | Recruiting | Chandigarh | 160047 | India |
| All India Institute of Medical Sciences, Jodhpur | Recruiting | Jodhpur | 342005 | India |
| Tata Medical Center | Recruiting | Kolkata | 700160 | India |
| Christian Medical College (CMC) & Hospital, Ludhiana | Recruiting | Ludhiana | 141008 | India |
| Madhepura Christian Hospital | Recruiting | Madhepura | 852113 | India |
| Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital | Recruiting | Mumbai | 400008 | India |
| Tata Memorial Hospital | Recruiting | Mumbai | 400012 | India |
| Maulana Azad Medical College | Recruiting | New Delhi | 110002 | India |
| All India Institute of Medical Sciences, Rishikesh | Recruiting | Rishikesh | 249203 | India |
| Christian Medical College & Hospital Vellore | Recruiting | Vellore | 632004 | India |
| Centro Médico Nacional de Occidente IMSS | Recruiting | Belisario Domínguez | 44329 | Mexico |
| Hospital Espanola Veracruz | Recruiting | Veracruz | 91700 | Mexico |
| University of Benin Teaching Hospital | Recruiting | Benin City | 300283 | Nigeria |
| University Of Abuja Teaching Hospital | Recruiting | Gwagwalada | 902101 | Nigeria |
| University College Hospital | Recruiting | Ibadan | 200285 | Nigeria |
| Obafemi Awolowo University Teaching Hospitals Complex | Recruiting | Ile-Ife | 233285 | Nigeria |
| University of Ilorin Teaching Hospital | Recruiting | Ilorin | 241102 | Nigeria |
| Ahmadu Bello University Teaching Hospital | Not yet recruiting | Kaduna | 810105 | Nigeria |
| Aminu Kano Teaching Hospital | Not yet recruiting | Kano | 700101 | Nigeria |
| Lagos State University Teaching Hospital | Recruiting | Lagos | 101233 | Nigeria |
| Lagos University Teaching Hospital | Recruiting | Lagos | 102215 | Nigeria |
| Nnamdi Azikiwe University Teaching Hospital | Not yet recruiting | Nnewi | 435101 | Nigeria |
| Tygerberg Hospital | Recruiting | Cape Town | 7505 | South Africa |
| Groote Schuur Hospital | Recruiting | Cape Town | 7925 | South Africa |
| New Somerset Hospital | Recruiting | Cape Town | 8001 | South Africa |
| Paarl Provincial Hospital | Recruiting | Paarl | 7646 | South Africa |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011014 | Pneumonia |
| D013530 | Surgical Wound Infection |
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D003141 | Communicable Diseases |
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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