Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000059561
Ethics application status
Approved
Date submitted
5/12/2023
Date registered
25/01/2024
Date last updated
25/01/2024
Date data sharing statement initially provided
25/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the impact of cleaning the surgical wound immediately after wound closure on bacterial growth on the skin
Scientific title
Effect of Surgical Site Cleaning on Bacterial Growth and Wound Disturbance in Patients undergoing Primary Total Hip and Knee Arthroplasty: A randomised controlled trial.
Secondary ID [1] 311121 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
wound disturbance 332281 0
Condition category
Condition code
Surgery 328995 328995 0 0
Other surgery
Musculoskeletal 329092 329092 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be divided into 3 groups.
There is only a single intervention performed in the operating theatre after the wound closure.
Swabs will be taken by the operating surgeon after wound closure and sent to pathology on the special form approved for the trial.
Swab results will be reviewed by the one of the associate investigators and record maintained under individual patient profile.

In the first intervention group, surgical site will be cleaned with surgical sponge soaked in 30 ml sterile Chlorhexidine antiseptic solution, dried with a sterile sponge and swab taken from surgical site followed by application of sterile dressing.

In the second intervention group, surgical site will be cleaned with surgical sponge soaked in 0.9 % Normal saline solution, then dried with a sterile sponge and swab taken from surgical site followed by application of sterile dressing.
Intervention code [1] 327568 0
Prevention
Comparator / control treatment

In the control group, wound would be wiped dry around the edges and dressed. No solutions will be used
Control group
Active

Outcomes
Primary outcome [1] 336784 0
Bacterial count on the surgical wound.
Timepoint [1] 336784 0
outcome will be assessed at 2 and 6 weeks after the intervention
Secondary outcome [1] 429669 0
wound disturbance in a surgical wound post cleaning with Normal saline and Chlorhexidine antiseptic solution.
Timepoint [1] 429669 0
2 and 6 weeks post intervention

Eligibility
Key inclusion criteria
1. Patients undergoing Primary Total Hip and Knee Arthroplasty
2. Patients should be able to provide consent either independently or through an interpreter
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring revision surgery
Patients with previous wound issues including wound or deep joint infection
Patients with dermatological problems such as psoriasis or severe eczema or similar conditions that may affect skin healing potential.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be allocated to one of three groups using computer-based block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will be randomized 1:1:1 to the dry wound cleaning versus the wound cleaning with either normal saline or chlorhexidine solution. The randomization sequence will be computer-generated using a block size of 6. Participants will be blinded to treatment group. Surgeons will not be blinded to treatment group but their involvement in study outcomes is minimized by data collection done through two investigators who are blinded to study arm. Research officers entering the data will not be blind to treatment allocation
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Using G*Power version 3.1.9.7 to carry out the calculation of sample size, based on an intermediate effect size of 0.25, power of 80%, and type I error of 0.05, we will have at least 53 participants in each of the three groups for one-way analysis of variance. Based on the aforementioned parameters, the estimated sample size is at least 159. Given the possibility of participants withdrawing from the study, we proposed to increase the sample size by 20 % which brings the total number of participants that will be randomised to 192. Participants will be allocated to one of three groups using computer-based block randomization.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/07/2023
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
192
Accrual to date
130
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25914 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 41749 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 315379 0
Hospital
Name [1] 315379 0
Department of Orthopaedics, Nepean Hospital
Country [1] 315379 0
Australia
Primary sponsor type
Hospital
Name
Department of Orthopaedics
Address
Nepean Hospital. PO Box 63, Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 317439 0
None
Name [1] 317439 0
Address [1] 317439 0
Country [1] 317439 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314295 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 314295 0
Ethics committee country [1] 314295 0
Australia
Date submitted for ethics approval [1] 314295 0
09/01/2023
Approval date [1] 314295 0
07/07/2023
Ethics approval number [1] 314295 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131098 0
Dr Ali Moaaz
Address 131098 0
Department of Orthopaedics, Nepean Hospital, PO Box 63, Penrith NSW 2751.
Country 131098 0
Australia
Phone 131098 0
+61413834977
Fax 131098 0
Email 131098 0
[email protected]
Contact person for public queries
Name 131099 0
Jennifer Smith
Address 131099 0
Clinical Nurse Coordinator, Department of Orthopaedics, Nepean Hospital. PO Box 63, Penrith NSW 2751
Country 131099 0
Australia
Phone 131099 0
+61 02 47341248
Fax 131099 0
Email 131099 0
[email protected]
Contact person for scientific queries
Name 131100 0
Ali Moaaz
Address 131100 0
Department of Orthopaedics, Nepean Hospital, PO Box 63, Penrith NSW 2751.
Country 131100 0
Australia
Phone 131100 0
+61413834977
Fax 131100 0
Email 131100 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
All individual patient data will be deidentified and stay confidential.


What supporting documents are/will be available?

No Supporting Document Provided



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.