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Improving respiratory care for patients having high-risk abdominal surgery

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

Phase 3 Interventional University of Birmingham · NCT04256798

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

PhasePhase 3
Study typeInterventional
Enrollment12942 (estimated)
Ages10 Years to 100 Years
SexAll
SponsorUniversity of Birmingham Academic / other
Locations37 sites (Botucatu, São Paulo and 36 other locations)
Trial IDNCT04256798 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients undergoing caesarean sections or those with documented allergies to chlorhexidine may not benefit from this study.

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 performed: 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.

Eligibility criteria

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 this trial is running

Botucatu, São Paulo and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions InfectionPneumoniaSurgical Site InfectionWound InfectionSurgical Wound InfectionPostoperative ComplicationsAnesthesiaCommunicable Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.