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

University of Birmingham

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: Oxygen; Drug: Chlorhexidine mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT04256798

RG_19-223

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 12,942 estimated patients

Sex: All

Ages: 10 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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12,942 participants in 4 patient groups

Mouthwash and liberal oxygen during surgery

Experimental group

Description:

Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 80-100% FiO2 during surgery.

Treatment:

Drug: Oxygen

Drug: Oxygen

Drug: Chlorhexidine mouthwash

No mouthwash and liberal oxygen during surgery

Active Comparator group

Description:

No pre-surgical mouthwash in combination with 80-100% FiO2 during surgery.

Treatment:

Drug: Oxygen

Drug: Oxygen

Mouthwash and restrictive oxygen during surgery

Experimental group

Description:

Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 21-30% FiO2 during surgery.

Treatment:

Drug: Oxygen

Drug: Oxygen

Drug: Chlorhexidine mouthwash

No mouthwash and restrictive oxygen during surgery

Active Comparator group

Description:

No pre-surgical mouthwash in combination with 21-30% FiO2 during surgery.

Treatment:

Drug: Oxygen

Drug: Oxygen