Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
Recruiting
Phase 3
Interventional Study
Infection
Pneumonia
Surgical Site Infection
Wound Infection
Surgical Wound Infection
Postoperative Complications
Anesthesia
Communicable Disease
Pathologic Processes
Perioperative Complication
Chlorhexidine
Laparotomy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 10 – 100
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 12,942 (estimated)
- Sponsor
- University of Birmingham · Other
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About This Trial
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 p…
Trial Locations
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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 under…
Contacts