Status:
RECRUITING
Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
Lead Sponsor:
University of Birmingham
Conditions:
Infection
Pneumonia
Eligibility:
All Genders
10-100 years
Phase:
PHASE3
Brief 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...
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 pn...
Eligibility 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)
Key Trial Info
Start Date :
November 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
12942 Patients enrolled
Trial Details
Trial ID
NCT04256798
Start Date
November 13 2020
End Date
June 1 2026
Last Update
February 19 2025
Active Locations (37)
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1
Hospital das Clinicas da Faculdade de Medicina de Botucatu - UNESP
Botucatu, São Paulo, Brazil
2
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
3
Hospital Nossa Senhora da Conceicao
Porto Alegre, Brazil
4
Hospital Universitario Professor Edgar Santos/Bahia
Salvador, Brazil