Clinical trial NCT04256798: Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Infection
Pneumonia
Surgical Site Infection
Wound Infection
Surgical Wound Infection
Postoperative Complications
Anesthesia
Communicable Disease
Pathologic Processes
Perioperative Complication
Chlorhexidine
Laparotomy
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 12942
Sex: ALL
Minimum age (years): 10
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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 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)

Primary outcomes:
measure: Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia (Mouthwash intervention only)
timeFrame: Within 30 days post-surgery from index operation
measure: Number of participants with surgical site infection (Oxygen therapy intervention only)
timeFrame: Within 30 days post-surgery from index operation
Secondary outcomes:
measure: Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons)
timeFrame: Within 30 days post-surgery from index operation
measure: Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only)
timeFrame: Within 30 days post-surgery from index operation
measure: Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions)
timeFrame: Within 30 days post-surgery from index operation
measure: Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions)
timeFrame: Within 30-days post surgery from index operation
measure: Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions)
timeFrame: Within 30 days post-surgery from index operation
measure: Number of participants admissions to a critical care unit (Mouthwash and oxygen therapy interventions)
timeFrame: Within 30 days post-surgery from index operation
measure: Health resource usage per patient
timeFrame: Within 30 days post-surgery from index operation
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Botucatu - UNESP
state: SP
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
city: Salvador
country: Brazil
facility: Hospital Universitario Professor Edgar Santos/Bahia
city: São José
country: Brazil
facility: Hospital Sao Jose - Criciuma/SC
city: Visakhapatnam
country: India
facility: Homi Bhabha Cancer Hospital & Research Centre
state: Andhra Pradesh
city: Srinagar
country: India
facility: Sher - i - Kashmir Institute of Medical Sciences
state: Jammu And Kashmir
city: Chinchpada
country: India
facility: Chinchpada Christian Hospital
state: Maharashtra
city: Madhava Nagar
country: India
facility: Kasturba Medical College Hospital, Manipal
state: Manipal, Karnataka
city: Patiala
country: India
facility: Government Medical College, Patiala
state: Punjab
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences, Bhubaneswar
city: Chandigarh
country: India
facility: Government Medial College & Hospital, Chandigarh
city: Jodhpur
country: India
facility: All India Institute of Medical Sciences, Jodhpur
city: Kolkata
country: India
facility: Tata Medical Center
city: Ludhiana
country: India
facility: Christian Medical College (CMC) & Hospital, Ludhiana
city: Madhepura
country: India
facility: Madhepura Christian Hospital
city: Mumbai
country: India
facility: Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: New Delhi
country: India
facility: Maulana Azad Medical College
city: Rishīkesh
country: India
facility: All India Institute of Medical Sciences, Rishikesh
city: Vellore
country: India
facility: Christian Medical College & Hospital Vellore
city: Belisario Domínguez
country: Mexico
facility: Centro Médico Nacional de Occidente IMSS
city: Veracruz
country: Mexico
facility: Hospital Espanola Veracruz
city: Benin City
country: Nigeria
facility: University of Benin Teaching Hospital
city: Gwagwalada
country: Nigeria
facility: University Of Abuja Teaching Hospital
city: Ibadan
country: Nigeria
facility: University College Hospital
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospitals Complex
city: Ilorin
country: Nigeria
facility: University of Ilorin Teaching Hospital
city: Kaduna
country: Nigeria
facility: Ahmadu Bello University Teaching Hospital
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
city: Lagos
country: Nigeria
facility: Lagos State University Teaching Hospital
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
city: Nnewi
country: Nigeria
facility: Nnamdi Azikiwe University Teaching Hospital
city: Cape Town
country: South Africa
facility: Tygerberg Hospital
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Cape Town
country: South Africa
facility: New Somerset Hospital
city: Paarl
country: South Africa
facility: Paarl Provincial Hospital
Study officials:
affiliation: Royal London Hospital
name: Rupert Pearse
role: PRINCIPAL_INVESTIGATOR
References: