Clinical trial Recruiting at 34 sites Phase 3 Interventional Ages 10 to 100

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

PhasePhase 3
Study typeInterventional
Ages10 Years to 100 Years
SexAll
Enrollment12942 (estimated)
SponsorUniversity of Birmingham
Academic / other
Locations37 sites (Botucatu, São Paulo and 36 other locations)
StatusRecruiting
StartedNovember 13, 2020
Main results expectedOctober 31, 2025
Study endsJune 1, 2026
Registry record updatedFebruary 19, 2025
Trial IDNCT04256798 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.