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NCT Number: NCT04256798

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

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.

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Key information

Conditions

Infection Anesthesia Chlorhexidine Communicable Disease Communicable Diseases Disease Attributes Infections Laparotomy Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative Complication Pneumonia Postoperative Complications Respiratory Tract Diseases Respiratory Tract Infections Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

10 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital das Clinicas da Faculdade de Medicina de Botucatu - UNESP, Botucatu, São Paulo, Brazil

Loading trial locations.

About this study

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 pneumonia rates in patients undergoing surgery with an abdominal incision.

Pneumonia is one of the most serious complications to occur after surgery, accounting for up to one in four of all postoperative deaths. The incidence is greater still in high-risk populations such as those undergoing midline laparotomy where mortality rates are more than 10%. SSIs are clearly important being the most frequent healthcare-associated infection in LMICs, affecting one in three patients undergoing contaminated or dirty surgery (34, 35). SSIs cause pain, discomfort and disability. They increase the time taken to return to work, and healthcare costs

The risk of postoperative mortality and complications such as surgical site infection is three times greater in low and middle-income countries (LMICs) than in high-income countries. In order to address surgical need worldwide, it is estimated that provision of a further 312 million operations would be required each year.

Patients will be recruited from hospitals in Low and Middle Income Countries (LMICs) who are undergoing elective or emergency mid-line laparotomy. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between:

A. Preoperative chlorhexidine mouthwash and 80-100% FiO2 during surgery B. No preoperative chlorhexidine mouthwash and 80-100% FiO2 during surgery C. Preoperative chlorhexidine mouthwash and 21-30% FiO2 during surgery D. No preoperative chlorhexidine mouthwash and 21-30% FiO2 during surgery

The 6 month internal pilot will assess the feasibility of recruitment, compliance with treatment allocation and patient retention and follow-up rates. The main Randomised Control Trial will recruit 12,924 participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chlorhexidine mouthwash

Drug

0.2% Chlorhexidine digluconate

Oxygen

Drug

Oxygen 80-100%

Primary outcomes

  1. Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia (Mouthwash intervention only)

    Time frame: Within 30 days post-surgery from index operation

    Pneumonia will be classified using the US Centers for Disease Control (CDC) definition of pneumonia

  2. Number of participants with surgical site infection (Oxygen therapy intervention only)

    Time frame: Within 30 days post-surgery from index operation

    The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision AND The patient must have at least one of the following:

    • Purulent drainage from the wound
    • Organisms are detected from a wound swab
    • Wound opened spontaneously or by a clinician AND, fever (>38°C), OR at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat;
    • Diagnosis of SSI by a clinician or radiological imaging

Secondary outcomes

  1. Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons)

    Time frame: Within 30 days post-surgery from index operation

    Patient mortality status

  2. Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only)

    Time frame: Within 30 days post-surgery from index operation

    Repeat abdominal surgery to treat complications

  3. Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions)

    Time frame: Within 30 days post-surgery from index operation

    Repeat abdominal surgery

  4. Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions)

    Time frame: Within 30-days post surgery from index operation

    Length of hospital stay for index admission will be collected and will measure time from surgery to time of discharge.

  5. Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions)

    Time frame: Within 30 days post-surgery from index operation

    Return to normal activities (e.g. work, school, or family duties) ascertained by trial specific case report forms.

  6. Number of participants admissions to a critical care unit (Mouthwash and oxygen therapy interventions)

    Time frame: Within 30 days post-surgery from index operation

    Admission to a critical care unit will be captured on the trial case report forms.

  7. Health resource usage per patient

    Time frame: Within 30 days post-surgery from index operation

    Resource use data will be collected as part of the economic evaluation of the different treatment combinations in a sub-group of adult patients at selected centers.

    Information related to post-operative cost (medicinal products, amenities and personal) will be collected on a health resource usage case report form designed by the trials health economist.

Study contacts

Contact information is provided by the study sponsor or research team.

Divya Kapoor

CONTACT

[email protected]

01214159127

Rachel Lillywhite, BA

CONTACT

[email protected]

01214159127

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Registry information

Official study 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

Acronym: PENGUIN

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Feb 5, 2020
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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