Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000076572
Ethics application status
Approved
Date submitted
18/12/2023
Date registered
30/01/2024
Date last updated
30/01/2024
Date data sharing statement initially provided
30/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clindamycin and bacterial load reduction as prophylaxis for surgical site infection after below-knee flap and graft procedures: a trial protocol.
Scientific title
Clindamycin and bacterial load reduction as prophylaxis for surgical site infection after below-knee flap and graft procedures in patients requiring surgical management of skin cancer below the knee: a trial protocol.
Secondary ID [1] 311202 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 332379 0
Surgical site infection 332380 0
Condition category
Condition code
Skin 329091 329091 0 0
Dermatological conditions
Cancer 329259 329259 0 0
Non melanoma skin cancer
Cancer 329260 329260 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment arms will be:
• Arm 1 – Bacterial load reduction: Patients will be screened nasally for S. aureus carriage seven to ten days pre-operatively. Those positive for S. aureus will receive nasal mupirocin ointment to be applied to the anterior nares (0.5ml of mupirocin 2% w/v ointment) nightly for three consecutive days pre-operatively. All patients will use an all-over chlorhexidine body wash (minimum 50ml of Chlorhexidine gluconate 4% w/v solution) the night before and morning of the surgery and receive placebo antibiotics as per those is arm 3 – Control.
• Arm 2 – Clindamycin: Patients will be administered 450mg of oral clindamycin 30-60 mins before surgery in the waiting room to enable monitoring for adverse reactions and an equal second dose at home 6hrs post-surgery Participants will perform a placebo bacterial load reduction following the same protocol as in Arm 1.
Participants will be asked to complete a treatment diary to monitor adherence to the intervention.
Intervention code [1] 327652 0
Prevention
Intervention code [2] 327653 0
Treatment: Drugs
Comparator / control treatment
Arm 3 – Control: This group represents normal standard of care in which no active bacterial load reduction or active clindamycin will be administered. Patients will receive placebo oral capsules containing an inert vehicle powder for clindamycin (in lieu of clindamycin), placebo saline wash (in lieu of chlorhexidine) and placebo soft white paraffin ointment (in lieu of nasal mupirocin). Placebo treatments will follow the same time schedule as their active counterparts in arms 1 and 2.
Control group
Placebo

Outcomes
Primary outcome [1] 336909 0
Incidence of postoperative surgical site infection
Timepoint [1] 336909 0
Day 14 post surgery. Day 28 post surgery to assess for delayed infection.
Secondary outcome [1] 430136 0
Adverse reactions to clindamycin
Timepoint [1] 430136 0
Within 30 days of surgery
Secondary outcome [2] 430139 0
Microbiology of infected wounds
Timepoint [2] 430139 0
Within first 30 days post surgery
Secondary outcome [3] 430141 0
Cost analysis
Timepoint [3] 430141 0
Within 30 days from time of surgery
Secondary outcome [4] 430632 0
Adverse reactions to chlorhexidine wash
Timepoint [4] 430632 0
Within 30 days of surgery
Secondary outcome [5] 430633 0
Adverse reactions to topical mupirocin
Timepoint [5] 430633 0
Within 30 days of surgery
Secondary outcome [6] 430634 0
Patterns of antibiotic resistance
Timepoint [6] 430634 0
At 30 days post surgery

Eligibility
Key inclusion criteria
Patients presenting to recruiting skin cancer clinics for surgical management of skin cancer below the knee which requires a complex surgical technique (flap or graft repair).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to clindamycin, chlorhexidine or mupirocin; existing skin infection; unable to provide informed consent; peripheral vascular disease; diabetes; current use of antibiotics; clinical indication for antibiotic treatment following excision (e.g. valvular heart disease).

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sequence generated by a computer-generated random number table
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
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/02/2025
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
155
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315462 0
University
Name [1] 315462 0
James Cook University
Country [1] 315462 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Drive James Cook University QLD 4811
Country
Australia
Secondary sponsor category [1] 317531 0
None
Name [1] 317531 0
Address [1] 317531 0
Country [1] 317531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314371 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314371 0
100 Angus Smith Drive Douglas QLD 4814
Ethics committee country [1] 314371 0
Australia
Date submitted for ethics approval [1] 314371 0
22/09/2023
Approval date [1] 314371 0
12/12/2023
Ethics approval number [1] 314371 0
90257

Summary
Brief summary
This study will investigate the effectiveness of two interventions to prevent surgical site infection after below-knee surgery for skin cancer in adults.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a skin cancer below the knee which requires a complex surgical technique (flap or graft repair), and you are a patient at one of the participating centres in Queensland.

Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups. Participants allocated to the first group will be asked to take an oral tablet pre- and post-surgery, use an antibacterial body wash prior to their surgery and may be asked to apply an antibacterial ointment to their nostrils as determined by the study team. Participants allocated to the second group will also be asked to take a pre- and post-surgery antibiotic dose and use a provided body wash prior to their surgery. Participants allocated to the third group will be asked to take an oral tablet pre- and post-surgery and use a provided body wash prior to their surgery.

It is hoped this research will determine whether use of oral antibiotics with or without antibacterial body wash has any impact on the incidence of post-surgical skin infections in patients undergoing surgical removal of below the knee skin cancers. If one or both of these measures is found to be effective, a larger trial enrolling a greater number of participants may be undertaken.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131338 0
Dr Helena Rosengren
Address 131338 0
Skin Repair Skin Cancer Clinic Townsville, 66 Mooney Street, Gulliver, Townsville, QLD, 4812
Country 131338 0
Australia
Phone 131338 0
+61 07 4779 0099
Fax 131338 0
Email 131338 0
helena@skinrepair.net.au
Contact person for public queries
Name 131339 0
Dr Helena Rosengren
Address 131339 0
Skin Repair Skin Cancer Clinic Townsville, 66 Mooney Street, Gulliver, Townsville, QLD, 4812
Country 131339 0
Australia
Phone 131339 0
+61 07 4779 0099
Fax 131339 0
Email 131339 0
helena@skinrepair.net.au
Contact person for scientific queries
Name 131340 0
Dr Helena Rosengren
Address 131340 0
Skin Repair Skin Cancer Clinic Townsville, 66 Mooney Street, Gulliver, Townsville, QLD, 4812
Country 131340 0
Australia
Phone 131340 0
+61 07 4779 0099
Fax 131340 0
Email 131340 0
helena@skinrepair.net.au

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?

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.