Improving respiratory care for patients having high-risk abdominal surgery
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
Run by University of Birmingham · NCT04256798 · Data updated 2026-11-12
This study is testing whether using a special mouthwash and different amounts of oxygen before surgery can help reduce the chances of pneumonia and infections in patients having major abdominal surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 10 Years to 100 Years |
| Sex | All |
| Enrollment | 12942 (estimated) |
| Sponsor | University of Birmingham Academic / other |
| Locations | 37 sites (Botucatu, São Paulo and 36 other locations) |
| Status | Recruiting |
| Started | November 13, 2020 |
| Main results expected | October 31, 2025 |
| Study ends | June 1, 2026 |
| Registry record updated | February 19, 2025 |
| Trial ID | NCT04256798 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults and children aged 10 years or older who are undergoing elective or emergency midline laparotomy with an anticipated incision of at least 5cm.
✕Probably not a fit
Patients undergoing caesarean sections or those with documented allergies to chlorhexidine may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The PENGUIN trial is a pragmatic, multi-center, randomized controlled trial aimed at evaluating the effects of pre-operative chlorhexidine mouthwash and varying levels of oxygen on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. Participants will be randomly assigned to one of four treatment groups to assess the impact of these interventions on post-operative complications. The study focuses on patients from low and middle-income countries, where the risk of surgical complications is significantly higher. By implementing these interventions, the trial seeks to improve surgical outcomes and reduce healthcare-associated infections.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of pneumonia and surgical site infections in high-risk surgical patients, leading to better recovery outcomes.
How similar studies have gone: Other studies have shown success with similar interventions aimed at reducing post-operative complications, but this specific approach in low and middle-income countries is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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)
Where it's running
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Hospital das Clinicas da Faculdade de Medicina de Botucatu - UNESP
Botucatu, São Paulo, Brazil Recruiting -
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil Recruiting -
Hospital Nossa Senhora da Conceicao
Porto Alegre, Brazil Recruiting -
Hospital Universitario Professor Edgar Santos/Bahia
Salvador, Brazil Recruiting -
Hospital Sao Jose - Criciuma/SC
São José, Brazil Recruiting -
Homi Bhabha Cancer Hospital & Research Centre
Visakhapatnam, Andhra Pradesh, India Recruiting
Show 31 more locations
-
Sher - i - Kashmir Institute of Medical Sciences
Srinagar, Jammu and Kashmir, India Recruiting -
Chinchpada Christian Hospital
Chinchpāda, Maharashtra, India Recruiting -
Kasturba Medical College Hospital, Manipal
Madhava Nagar, Manipal, Karnataka, India Recruiting -
Government Medical College, Patiala
Patiāla, Punjab, India Recruiting -
All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, India Recruiting -
Government Medial College & Hospital, Chandigarh
Chandigarh, India Recruiting -
All India Institute of Medical Sciences, Jodhpur
Jodhpur, India Recruiting -
Tata Medical Center
Kolkata, India Recruiting -
Christian Medical College (CMC) & Hospital, Ludhiana
Ludhiana, India Recruiting -
Madhepura Christian Hospital
Madhepura, India Recruiting -
Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital
Mumbai, India Recruiting -
Tata Memorial Hospital
Mumbai, India Recruiting -
Maulana Azad Medical College
New Delhi, India Recruiting -
All India Institute of Medical Sciences, Rishikesh
Rishikesh, India Recruiting -
Christian Medical College & Hospital Vellore
Vellore, India Recruiting -
Centro Médico Nacional de Occidente IMSS
Belisario Domínguez, Mexico Recruiting -
Hospital Espanola Veracruz
Veracruz, Mexico Recruiting -
University of Benin Teaching Hospital
Benin City, Nigeria Recruiting -
University Of Abuja Teaching Hospital
Gwagwalada, Nigeria Recruiting -
University College Hospital
Ibadan, Nigeria Recruiting -
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Nigeria Recruiting -
University of Ilorin Teaching Hospital
Ilorin, Nigeria Recruiting -
Lagos State University Teaching Hospital
Lagos, Nigeria Recruiting -
Lagos University Teaching Hospital
Lagos, Nigeria Recruiting -
Tygerberg Hospital
Cape Town, South Africa Recruiting -
Groote Schuur Hospital
Cape Town, South Africa Recruiting -
New Somerset Hospital
Cape Town, South Africa Recruiting -
Paarl Provincial Hospital
Paarl, South Africa Recruiting -
Ahmadu Bello University Teaching Hospital
Kaduna, Nigeria Not yet recruiting -
Aminu Kano Teaching Hospital
Kano, Nigeria Not yet recruiting -
Nnamdi Azikiwe University Teaching Hospital
Nnewi, Nigeria Not yet recruiting
Study contacts
- Principal investigator: Rupert Pearse — Royal London Hospital
- Study coordinator: Divya Kapoor
- Email: penguin@trials.bham.ac.uk
- Phone: 01214159127
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.