Actively Recruiting

Phase 3
Age: 10Years - 100Years
All Genders
NCT04256798

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

Led by University of Birmingham · Updated on 2025-02-19

12942

Participants Needed

37

Research Sites

289 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 10Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

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Trial Site Locations

Total: 37 locations

1

Hospital das Clinicas da Faculdade de Medicina de Botucatu - UNESP

Botucatu, São Paulo, Brazil

Actively Recruiting

2

Hospital de Clinicas de Porto Alegre

Porto Alegre, Brazil

Actively Recruiting

3

Hospital Nossa Senhora da Conceicao

Porto Alegre, Brazil

Actively Recruiting

4

Hospital Universitario Professor Edgar Santos/Bahia

Salvador, Brazil

Actively Recruiting

5

Hospital Sao Jose - Criciuma/SC

São José, Brazil

Actively Recruiting

6

Homi Bhabha Cancer Hospital & Research Centre

Visakhapatnam, Andhra Pradesh, India, 530053

Actively Recruiting

7

Sher - i - Kashmir Institute of Medical Sciences

Srinagar, Jammu and Kashmir, India, 190011

Actively Recruiting

8

Chinchpada Christian Hospital

Chinchpāda, Maharashtra, India, 425417

Actively Recruiting

9

Kasturba Medical College Hospital, Manipal

Madhava Nagar, Manipal, Karnataka, India, 576104

Actively Recruiting

10

Government Medical College, Patiala

Patiāla, Punjab, India, 147001

Actively Recruiting

11

All India Institute of Medical Sciences, Bhubaneswar

Bhubaneswar, India, 751019

Actively Recruiting

12

Government Medial College & Hospital, Chandigarh

Chandigarh, India, 160047

Actively Recruiting

13

All India Institute of Medical Sciences, Jodhpur

Jodhpur, India, 342005

Actively Recruiting

14

Tata Medical Center

Kolkata, India, 700160

Actively Recruiting

15

Christian Medical College (CMC) & Hospital, Ludhiana

Ludhiana, India, 141008

Actively Recruiting

16

Madhepura Christian Hospital

Madhepura, India, 852113

Actively Recruiting

17

Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital

Mumbai, India, 400008

Actively Recruiting

18

Tata Memorial Hospital

Mumbai, India, 400012

Actively Recruiting

19

Maulana Azad Medical College

New Delhi, India, 110002

Actively Recruiting

20

All India Institute of Medical Sciences, Rishikesh

Rishikesh, India, 249203

Actively Recruiting

21

Christian Medical College & Hospital Vellore

Vellore, India, 632004

Actively Recruiting

22

Centro Médico Nacional de Occidente IMSS

Belisario Domínguez, Mexico, 44329

Actively Recruiting

23

Hospital Espanola Veracruz

Veracruz, Mexico, 91700

Actively Recruiting

24

University of Benin Teaching Hospital

Benin City, Nigeria, 300283

Actively Recruiting

25

University Of Abuja Teaching Hospital

Gwagwalada, Nigeria, 902101

Actively Recruiting

26

University College Hospital

Ibadan, Nigeria, 200285

Actively Recruiting

27

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Nigeria, 233285

Actively Recruiting

28

University of Ilorin Teaching Hospital

Ilorin, Nigeria, 241102

Actively Recruiting

29

Ahmadu Bello University Teaching Hospital

Kaduna, Nigeria, 810105

Not Yet Recruiting

30

Aminu Kano Teaching Hospital

Kano, Nigeria, 700101

Not Yet Recruiting

31

Lagos State University Teaching Hospital

Lagos, Nigeria, 101233

Actively Recruiting

32

Lagos University Teaching Hospital

Lagos, Nigeria, 102215

Actively Recruiting

33

Nnamdi Azikiwe University Teaching Hospital

Nnewi, Nigeria, 435101

Not Yet Recruiting

34

Tygerberg Hospital

Cape Town, South Africa, 7505

Actively Recruiting

35

Groote Schuur Hospital

Cape Town, South Africa, 7925

Actively Recruiting

36

New Somerset Hospital

Cape Town, South Africa, 8001

Actively Recruiting

37

Paarl Provincial Hospital

Paarl, South Africa, 7646

Actively Recruiting

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Research Team

D

Divya Kapoor

CONTACT

R

Rachel Lillywhite, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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