InfectionPhase 3PENGUINNCT04256798
Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
A Phase 3 study testing Chlorhexidine mouthwash and Oxygen in people with Infection and Pneumonia, run by University of Birmingham at 37 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 100 years
- Conditions the study is for
- Infection, Pneumonia, Surgical Site Infection
- What is being tested?
- Chlorhexidine mouthwash and Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,942 participants
- Where
- 37 sitesin 5 countries
- Study dates
- 13 Nov 2020to 1 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
37 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 5 countries
India16 sites, 16 recruiting
- Recruiting
All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, 751019
- Recruiting
Government Medial College & Hospital, Chandigarh
Chandigarh, 160047
- Recruiting
Chinchpada Christian Hospital
Chinchpāda, Maharashtra, 425417
- Recruiting
All India Institute of Medical Sciences, Jodhpur
Jodhpur, 342005
- Recruiting
Tata Medical Center
Kolkata, 700160
- Recruiting
Christian Medical College (CMC) & Hospital, Ludhiana
Ludhiana, 141008
- Recruiting
Kasturba Medical College Hospital, Manipal
Madhava Nagar, Manipal, Karnataka, 576104
- Recruiting
Madhepura Christian Hospital
Madhepura, 852113
- Recruiting
Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital
Mumbai, 400008
- Recruiting
Tata Memorial Hospital
Mumbai, 400012
- Recruiting
Maulana Azad Medical College
New Delhi, 110002
- Recruiting
Government Medical College, Patiala
Patiāla, Punjab, 147001
- Recruiting
All India Institute of Medical Sciences, Rishikesh
Rishikesh, 249203
- Recruiting
Sher - i - Kashmir Institute of Medical Sciences
Srinagar, Jammu and Kashmir, 190011
- Recruiting
Christian Medical College & Hospital Vellore
Vellore, 632004
- Recruiting
Homi Bhabha Cancer Hospital & Research Centre
Visakhapatnam, Andhra Pradesh, 530053
Nigeria10 sites, 10 recruiting
- Recruiting
University of Benin Teaching Hospital
Benin City, 300283
- Recruiting
University Of Abuja Teaching Hospital
Gwagwalada, 902101
- Recruiting
University College Hospital
Ibadan, 200285
- Recruiting
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, 233285
- Recruiting
University of Ilorin Teaching Hospital
Ilorin, 241102
- Not yet recruiting
Ahmadu Bello University Teaching Hospital
Kaduna, 810105
- Not yet recruiting
Aminu Kano Teaching Hospital
Kano, 700101
- Recruiting
Lagos State University Teaching Hospital
Lagos, 101233
- Recruiting
Lagos University Teaching Hospital
Lagos, 102215
- Not yet recruiting
Nnamdi Azikiwe University Teaching Hospital
Nnewi, 435101
Brazil5 sites, 5 recruiting
- Recruiting
Hospital das Clinicas da Faculdade de Medicina de Botucatu - UNESP
Botucatu, São Paulo
Leandro Gobbo Braz
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre
Luciana Cadore Stefani
- Recruiting
Hospital Nossa Senhora da Conceicao
Porto Alegre
ANDRE PRATO SCHMIDT
- Recruiting
Hospital Universitario Professor Edgar Santos/Bahia
Salvador
Liana Maria Torres De Araujo Azi
- Recruiting
Hospital Sao Jose - Criciuma/SC
São José
Eric Benedet Lineburger
South Africa4 sites, 4 recruiting
- Recruiting
Tygerberg Hospital
Cape Town, 7505
- Recruiting
Groote Schuur Hospital
Cape Town, 7925
- Recruiting
New Somerset Hospital
Cape Town, 8001
- Recruiting
Paarl Provincial Hospital
Paarl, 7646
Mexico2 sites, 2 recruiting
- Recruiting
Centro Médico Nacional de Occidente IMSS
Belisario Domínguez, 44329
- Recruiting
Hospital Espanola Veracruz
Veracruz, 91700
About this study
Official title: PErioperative Respiratory Care and Outcomes for patieNts Undergoing hIgh Risk abdomiNal Surgery: A 2x2 Factorial, International Pragmatic Randomised Controlled Trial Across Low and Middle-income Countries
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.
Read the detailed description
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:
- 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.
- Conditions
- Infection, Pneumonia, Surgical Site Infection, Wound Infection, Surgical Wound Infection, Postoperative Complications
- Being tested
- Chlorhexidine mouthwash, Oxygen
- Medical subject headings
- Infections, Pneumonia, Surgical Wound Infection, Wound Infection, Postoperative Complications, Communicable Diseases, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine mouthwashDrug
0.2% Chlorhexidine digluconate
OxygenDrug
Oxygen 80-100%
OxygenDrug
Oxygen 21-30 %
| Study group | Role | What they receive |
|---|---|---|
| Mouthwash and liberal oxygen during surgery | Experimental | Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 80-100% FiO2 during surgery. Receives: Drug: Chlorhexidine mouthwash; Drug: Oxygen |
| No mouthwash and liberal oxygen during surgery | Active comparator | No pre-surgical mouthwash in combination with 80-100% FiO2 during surgery. Receives: Drug: Oxygen |
| Mouthwash and restrictive oxygen during surgery | Experimental | Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 21-30% FiO2 during surgery. Receives: Drug: Chlorhexidine mouthwash; Drug: Oxygen |
| No mouthwash and restrictive oxygen during surgery | Active comparator | No pre-surgical mouthwash in combination with 21-30% FiO2 during surgery. Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Within 30 days post-surgery from index operation
Secondary outcomes (7)
Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons)
Patient mortality status
Measured: 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
Measured: Within 30 days post-surgery from index operation
Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions)
Repeat abdominal surgery
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 days post-surgery from index operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start13 Nov 2020
- Primary completion31 Oct 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12,942 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rupert Pearse, Principal investigator, Royal London Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256798
- Sponsor's protocol ID
- RG_19-223
- Acronym
- PENGUIN
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2020
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via a process of controlled access
Publications
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.
PubMed 40255646
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PErioperative Respiratory Care and Outcomes for patieNts Undergoing hIgh Risk abdomiNal Surgery: A 2x2 Factorial, International Pragmatic Randomised Controlled Trial Across Low and Middle-income Countries
- ClinicalTrials.gov ID
- NCT04256798
- Acronym / sponsor ID
- PENGUIN / RG_19-223
- Conditions
- Infection, Pneumonia, Surgical Site Infection, Wound Infection, Surgical Wound Infection, Postoperative Complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12,942 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mouthwash and liberal oxygen during surgery | Experimental | Drug: Chlorhexidine mouthwash, Drug: OxygenPre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 80-100% FiO2 during surgery. |
| No mouthwash and liberal oxygen during surgery | Active comparator | Drug: OxygenNo pre-surgical mouthwash in combination with 80-100% FiO2 during surgery. |
| Mouthwash and restrictive oxygen during surgery | Experimental | Drug: Chlorhexidine mouthwash, Drug: OxygenPre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 21-30% FiO2 during surgery. |
| No mouthwash and restrictive oxygen during surgery | Active comparator | Drug: OxygenNo pre-surgical mouthwash in combination with 21-30% FiO2 during surgery. |
Who may qualify
- Ages
- 10 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine mouthwash0.2% Chlorhexidine digluconate | Drug | Mouthwash and liberal oxygen during surgery, Mouthwash and restrictive oxygen during surgery |
| OxygenOxygen 80-100% | Drug | Mouthwash and liberal oxygen during surgery, No mouthwash and liberal oxygen during surgery |
| OxygenOxygen 21-30 % | Drug | Mouthwash and restrictive oxygen during surgery, No mouthwash and restrictive oxygen during surgery |
Primary outcome
Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia (Mouthwash intervention only)
Time frame: 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)
Time frame: 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
7 secondary outcomes
Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons)
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)
Time frame: Within 30 days post-surgery from index operation
Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions)
Time frame: Within 30 days post-surgery from index operation
Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions)
Time frame: Within 30-days post surgery from index operation
Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions)
Time frame: Within 30 days post-surgery from index operation
Number of participants admissions to a critical care unit (Mouthwash and oxygen therapy interventions)
Time frame: Within 30 days post-surgery from index operation
Health resource usage per patient
Time frame: Within 30 days post-surgery from index operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 40255646PENGUIN 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.
- Individual participant dataSharing planned: Yes. Data will be shared via a process of controlled access
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rupert Pearse principal investigator
Royal London Hospital
37 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorhexidine mouthwash and Oxygen in people with Infection and Pneumonia, run by University of Birmingham at 37 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in India, Nigeria, Brazil, South Africa, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Divya Kapoor (01214159127, penguin@trials.bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia (Mouthwash intervention only) (time frame: Within 30 days post-surgery from index operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04256798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.