Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000285752
Ethics application status
Approved
Date submitted
10/12/2020
Date registered
15/02/2022
Date last updated
15/02/2022
Date data sharing statement initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of pre-operative oral antibiotics on post-operative surgical site infections in patients undergoing elective colorectal surgery.
Scientific title
Colorectal Anti-Bacterial Eradication (CABE) Trial: The effect of pre-operative antibiotics on post-operative wound infections in Colorectal Surgery
Secondary ID [1] 302957 0
None
Universal Trial Number (UTN)
Trial acronym
CABE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Site Infections 319987 0
Venous thromboembolism 325180 0
Urinary tract infections 325181 0
Respiratory infections 325182 0
Gastrointestinal infections 325183 0
Mortality 325184 0
Condition category
Condition code
Infection 317920 317920 0 0
Other infectious diseases
Surgery 318239 318239 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-operative oral antibiotics vs Standard of care in patients undergoing elective colorectal surgery and the incidence of post-operative surgical site infections (SSI).

Drug trial

Control group: Participants randomised to the control group will receive the standard of care package for elective pre-operative colorectal surgery patients. Standard of care intervention includes:
1. Osmotic laxative satchets: 3 satchets - each satchet to be drunk with 250ml of water 1 day before the operation at 1200, 1400 and 1600
2. MRSA decolononisation: 2 x (4% chlorhexidine soap packets) - patients to use shower with 1 packet night before surgery and morning of surgery. If the soap packets were used incorrectly, chlorhexidine wipes will be used on the day of the surgery
3. Placebo pills - identical pills to the interventional pills to be taken at 1300, 1400 and 2200 day before surgery

Intervention group: Participants randomised to the interventional group will received the same items as the standard of care group but the placebo pills will be replaced with:
1. Neomycin Sulfate 1g and Metronidazole 400mg to be taken at 1300, 1400 and 2200 on the day before the operation
Intervention code [1] 319244 0
Treatment: Drugs
Comparator / control treatment
The control group compromises of participants randomised to the standard of care with the addition of placebo pills. Placebo pills will comprise of glucose capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 325929 0
Surgical Site Infection

The patient will be reviewed in person as an outpatient at 14 days and followed up with a questionnaire at 30 days following surgery for wound assessment. This is to ensure that patients are safe and treated appropriately should they develop an SSI. The validated Bluebelle Wound Healing Questionnaire form will be provided to participants to be filled up at these specific post-operative dates. Participants will be required to upload a picture (following a standard template that will be provided). The questionnaire and picture will be blinded and assessed by a Consultant Surgeon who will determine if the patient had a surgical site infection.
Timepoint [1] 325929 0
14 days and 30 days post-operation (primary timepoint)
Secondary outcome [1] 389565 0
Time fit for discharge

As assessed by the treating team prior to discharge. Surgical parameters such as symptoms and biochemistry markers will be used to assess fitness for discharge.
Timepoint [1] 389565 0
This will be assessed on the day that the treating team deems the patient fit for discharge.
Secondary outcome [2] 390580 0
Return to theatre for SSI debridement or washout

As assessed by the treating team. Surgical parameters such as symptoms, biochemistry markers and imaging will be used to assess return to theatre..
Timepoint [2] 390580 0
This will be assessed on the day that the treating team deems the patient requires re-operation for an SSI related incident.
Secondary outcome [3] 390581 0
Post- surgical complications/Infections including: pulmonary embolisms/deep vein thrombosis, urinary tract infections, respiratory infections, gastrointestinal infections

As assessed by the treating team. Surgical parameters such as symptoms, biochemistry markers and imaging will be used to diagnose post-surgical complications/infections according to ICD-10 classification.
Timepoint [3] 390581 0
This will be assessed on a daily basis during the course of the patient's in-patient stay in hospital. All events will be noted at 14 days and 30 days post-operation.
Secondary outcome [4] 390582 0
Mortality
Timepoint [4] 390582 0
This will be assessed on a daily basis during the course of the patient's in-patient stay in hospital. All events will be noted at 14 days and 30 days post-operation.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Patients undergoing elective open or laparoscopic colorectal resection
2. Able to give informed consent
3. Male or female patients from 18-60 years of age
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Pregnancy – determined through serum b-HCG
2. Terminal organ impairment
3. Patients that must return to theatre for pathology unrelated to surgical wound site infection such as anastomotic leaks, revisions or re-look laparotomy washouts
4. Evidence, preoperatively, of any of the following: sepsis, severe sepsis, or septic shock. Including antibiotic usage in the last 2 weeks
5. Patients with pre-existing renal failure – an arbitrary value of CrCl< 50mL/min
6. BMI > 40 as patients with morbid obesity will have higher mortality and SSI rates
7. Current abdominal wall infection/surgical site infection secondary to previous laparotomy/laparoscopy or from any other cause (including enterocutaneous fistulas)
8. History of laparotomy within the last 60 days
9. Immunological disease (e.g. HIV/AIDS)
10. Systemic steroid use or other immunosuppressant medication as they are at an increased risk of SSIs
11. ASA score greater than or equal to 4
12. Uncontrolled diabetes mellitus
13. Emergency Surgery
14. Allergy to aminoglycoside or nitroimidazole
15. Previous neoadjuvant chemotherapy within the last 4 weeks
16. Hearing loss
17. If antibiotics were not taken correctly prior to the surgery

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be determined through central randomisation with computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted with a computer software. Using 2 sets of 250 participants each (for a total of 500 participants).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis
All continuous variable data will be tested using the Shapiro Wilks test for normality, all data which have a normal distribution will be described using mean ± standard deviation. Data that is not normally distributed will be described with median and the intra-quartile range. Comparisons between groups, for example patients treated with standard of care versus BPB1 will be made by t-tests and analysis of variance (ANOVAs) for normally distributed data or the non-parametric equivalents Wilcoxon–Mann Whitney and Kruskal Wallis test for non-normally distributed data. Alternatively, we may use regression analysis (Generalised linear mixed models (GLMM) which can be used with non-normally distributed data.

Categorical data will be described as frequency (percentage) and compared using Fisher’s exact test or Chi squared test as appropriate. Investigation of what factors may statistically significantly modify or predict outcomes such as the patient’s recent medical history or their post-operative care will be investigated using regression analysis. The type of regression analysis will depend on the nature of the variables (whether continuous, interval or categorical, and their distribution) and how many independent and dependent variables are being compared (multivariate and/or multiple regression). Only 2-sides tests will be used, and p values of <0.05 deemed significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2022
Actual
Date of last participant enrolment
Anticipated
31/03/2026
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18156 0
Dandenong Hospital - Dandenong
Recruitment hospital [2] 18157 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 18158 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 32155 0
3199 - Frankston
Recruitment postcode(s) [2] 36714 0
3084 - Heidelberg
Recruitment postcode(s) [3] 36715 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 307375 0
Hospital
Name [1] 307375 0
Department of Colorectal Surgery, Dandenong Hospital, Monash Health
Country [1] 307375 0
Australia
Primary sponsor type
Individual
Name
Mr Asiri Arachchi
Address
Department of Colorectal Surgery, Dandenong Hospital, Monash Health, Victoria, Australia
135 David St, Dandenong VIC 3175, Victoria, Australia
Country
Australia
Secondary sponsor category [1] 308031 0
Individual
Name [1] 308031 0
Mr Vladimir Bolshinsky
Address [1] 308031 0
Colorectal Surgery, Peninsula Private Hospital
525 McClelland Dr, Frankston VIC 3199, Victoria, Australia
Country [1] 308031 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307462 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 307462 0
246 Clayton Rd, Clayton VIC 3168, Victoria, Australia
Ethics committee country [1] 307462 0
Australia
Date submitted for ethics approval [1] 307462 0
21/10/2020
Approval date [1] 307462 0
27/01/2022
Ethics approval number [1] 307462 0
RES-20-0000-777A

Summary
Brief summary
Study objectives

Objective: To utilise pre-operative antibiotics along with standard mechanical bowel preparation with an aim to reduce surgical site infection (SSI) in elective bowel resection surgery.

Hypothesis: Oral antibiotics as part of mechanical bowel preparation will reduce the incidence of SSI in post colectomy patients.

Study design:

This is a single blinded, randomised control trial, conducted under the Colorectal Surgery Unit of multiple health centres including Monash Health, Austin Health, Peninsula Health. This is in compliance with the National Statement on Ethical Conduct in Human Research of the National Health and Medical Research Council. Participants will be split into 2 arms, the control group receiving the placebo pills along with the standard of care package and the case group receiving oral antibiotics along with the standard of care package. The primary outcome of surgical site infections will be assessed at 14 days and 30 days post-surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107318 0
Mr Asiri Arachchi
Address 107318 0
Department of Colorectal Surgery, Dandenong Hospital, Monash Health, Victoria, Australia
135 David St, Dandenong VIC 3175
Country 107318 0
Australia
Phone 107318 0
+61 406018279
Fax 107318 0
Email 107318 0
[email protected]
Contact person for public queries
Name 107319 0
Mr Asiri Arachchi
Address 107319 0
Department of Colorectal Surgery, Dandenong Hospital, Monash Health, Victoria, Australia
135 David St, Dandenong VIC 3175
Country 107319 0
Australia
Phone 107319 0
+61 406018279
Fax 107319 0
Email 107319 0
[email protected]
Contact person for scientific queries
Name 107320 0
Mr Asiri Arachchi
Address 107320 0
Department of Colorectal Surgery, Dandenong Hospital, Monash Health, Victoria, Australia
135 David St, Dandenong VIC 3175
Country 107320 0
Australia
Phone 107320 0
+61 406018279
Fax 107320 0
Email 107320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9982Study protocol    381065-(Uploaded-11-02-2022-19-21-52)-Study-related document.docx
9983Informed consent form    381065-(Uploaded-08-02-2022-09-24-46)-Study-related document.docx
14980Ethical approval    381065-(Uploaded-08-02-2022-09-25-01)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9982[Marked for deletion] [Marked for deletion][Marked for deletion][Marked for deletion][Marked for deletion] [Marked for deletion]
9983Informed consent form    381065-(Uploaded-08-02-2022-09-24-46)-Study-related document.docx
14980Ethical approval    381065-(Uploaded-08-02-2022-09-25-01)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.