Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202009582570618 Date of Approval: 07/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
Official scientific 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
Brief summary describing the background and objectives of the trial 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 21-35% 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PENgUIN
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2020
Actual trial start date
Anticipated date of last follow up 03/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 12942
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mouthwash and Liberal Oxygen 0.2% chlorhexidine gluconate 15 mls 30 minutes before surgery 80-100% of fraction inspired oxygen during surgery Mouthwash - 30 second mouthwashes x 3 Inspired oxygen - throughout the duration of the surgery The trial includes two experimental arms with patients randomised to: - mouthwash before surgery followed by either 1) 21-35% fraction inspired oxygen (restrictive oxygen) or 2) 80-100% fraction inspired oxygen (liberal oxygen) - 80-100% fraction inspired oxygen after receiving 1) mouthwash or 2) no mouthwash 6471
Control Group No Mouthwash and restrictive oxygen Patient does not receive 0.2% chlorhexidine in the preoperative setting. Restrictive oxygen: 21-35% fraction inspired oxygen during surgery Not applicable for no mouthwash Restrictive, 21-35% fraction inspired oxygen will be administered for the duration of the surgery The trial includes two comparator arms with patients randomised to: - no mouthwash before surgery followed by either 1) 21-35% fraction inspired oxygen (restrictive oxygen) or 2) 80-100% fraction inspired oxygen (liberal oxygen) - 21-35% fraction inspired oxygen after receiving 1) mouthwash or 2) no mouthwash 6471 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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) 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) 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/03/2020 The Science Technology Engineering and Mathematics Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Birmingham Birmingham 0000 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia Within 30 days post-surgery from index operation
Primary Outcome Number of participants with surgical site infection Within 30 days post-surgery from index operation
Secondary Outcome Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons) Within 30 days post-surgery from index operation
Secondary Outcome Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only) Within 30 days post-surgery from index operation
Secondary Outcome Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions) Within 30 days post-surgery from index operation
Secondary Outcome Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions) Within 30 days post-surgery from index operation
Secondary Outcome Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions) Within 30 days post-surgery from index operation
Secondary Outcome Number of participants admissions to a critical care unit (Mouthwash and oxygen therapy interventions) Within 30 days post-surgery from index operation
Secondary Outcome Health resource usage per patient Within 30 days post-surgery from index operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Main Road, Observatory Cape Town 7937 South Africa
Wits Health Consortium St Andrews Street Johannesburg 2193 South Africa
Paarl Hospital Corner of Hospital and Bergriver Boulevard Paarl 7646 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Health Research Whitehall London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Birmingham Edgbaston Birmingham United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Bruce Biccard Main Road, Observatory Cape Town 7935 South Africa
Adesoji Ademuyiwa Lagos University Teaching Hospital Lagos 12003 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rupert Pearse r.pearse@qmul.ac.uk +442035940351 Royal London Hospital
City Postal code Country Position/Affiliation
London United Kingdom NIHR Research Professor and Consultant in Intensive Care Medicine
Role Name Email Phone Street address
Public Enquiries Matthew Soden penguin@trials.bham.ac.uk +441214144762 University of Birmingham
City Postal code Country Position/Affiliation
Birmingham United Kingdom Senior Trial Manager
Role Name Email Phone Street address
Scientific Enquiries Bruce Biccard bruce.biccard@uct.ac.za 0214045142 Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Second Professor and Second Chair in Anesthesia Deputy Head of Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A minimum summary results or a link to summary results within the trial would be shared within 12 months of completion Statistical Analysis Plan,Study Protocol Six months after the trial publication. Controlled access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information