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Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery

NCT04256798 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12942

Last updated 2025-02-19

No results posted yet for this study

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 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 pre-operative mouthwash and 80-100% fraction of inspired oxygen (FiO2); c) pre-operative chlorhexidine mouthwash and 21- 30% FiO2; or d) no pre-operative mouthwash and 21-30% FiO2.

Conditions

  • Infection
  • Pneumonia
  • Surgical Site Infection
  • Wound Infection
  • Surgical Wound Infection
  • Postoperative Complications
  • Anesthesia
  • Communicable Disease
  • Pathologic Processes
  • Perioperative Complication
  • Chlorhexidine
  • Laparotomy

Interventions

DRUG

Chlorhexidine mouthwash

0.2% Chlorhexidine digluconate

DRUG

Oxygen

Oxygen 80-100%

DRUG

Oxygen

Oxygen 21-30 %

Sponsors & Collaborators

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Rupert Pearse · Royal London Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
10 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2025-10-31
Completion
2026-06-01

Countries

  • Brazil
  • India
  • Mexico
  • Nigeria
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04256798 on ClinicalTrials.gov