Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000470493p
Ethics application status
Submitted, not yet approved
Date submitted
22/04/2025
Date registered
16/05/2025
Date last updated
16/05/2025
Date data sharing statement initially provided
16/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effects of metronidazole ointment for non-healing pilonidal sinus wounds in adults
Scientific title
Randomised, double-blind, placebo-controlled trial evaluating the effects of metronidazole ointment in facilitating resolution of non-healing pilonidal sinus wounds in adults
Secondary ID [1] 314395 0
NCT04273997
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is the Australian arm of NCT04273997

Health condition
Health condition(s) or problem(s) studied:
pilonidal sinus 337178 0
Condition category
Condition code
Surgery 333594 333594 0 0
Other surgery
Skin 333779 333779 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily for 8 weeks, or if the wound heals prior to the study end-point (ie before 8 weeks of treatment application), for 2weeks after complete wound healing is observed. The maximum duration of treatment will be 8 weeks.
One dose contains approximately 70 mg metronidazole in a formulation of white soft paraffin. The Investigator will demonstrate to the patient how to apply a 2.5 cm of ointment on clean dry gauze retained with tape. Larger wounds may require additional amount of ointment to ensure sufficient coverage of the wound.
Compliance with ointment application will be confirmed via a patient-recorded diary confirming daily application, as well as by weighing the ointment tube at each fortnightly review to ensure an appropriate weight reduction consistent with regular application has occured
Intervention code [1] 330868 0
Treatment: Drugs
Comparator / control treatment
Placebo ointment (contains titanium dioxide and white soft paraffin)
The placebo ointment does not contain any metronidazole
Control group
Placebo

Outcomes
Primary outcome [1] 341175 0
Proportion of patients with complete wound healing by week 8
Timepoint [1] 341175 0
8 weeks post commencement of treatment
Secondary outcome [1] 446649 0
Determine effect of topical metronidazole on the time course of wound healing
Timepoint [1] 446649 0
week 8 post treatment commencement
Secondary outcome [2] 446650 0
Determine the effects of metronidazole in promoting partial healing
Timepoint [2] 446650 0
week 8 post treatment commencement
Secondary outcome [3] 446652 0
Determine the effects of metronidazole on the patient’s global impression of improvement
Timepoint [3] 446652 0
week 8 post commencement of treatment
Secondary outcome [4] 446654 0
Evaluate the safety of metronidazole ointment in the treatment of non-healing pilonidal sinus wounds
Timepoint [4] 446654 0
Side effects or adverse events can be reported by patients at any time during their participation. Clinical assessments will occur on a fortnightly basis up to week 8 post treatment commencement

Eligibility
Key inclusion criteria
1. Must give written informed consent.
2. Male or female aged 18 years or over.
3. Previous surgery for pilonidal disease and failure of healing for a minimum of 6 weeks post-surgical excision of the pilonidal cyst/sinus;
4. Willingness to stop all other concomitant topical preparations at the site of pilonidal sinus wounds
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of undrained abscess (abscess must have been drained at least 6 weeks prior to entry), tunnels or pits.
2. Patients who are due to undergo surgery related to pilonidal sinus.
3. Previous use (in the last 2 weeks) or current treatment with any antibiotic. To be determined by medical history.
4. Previous treatment with topical metronidazole for pilonidal sinus.
5. Known allergic reaction to metronidazole.
6. Known allergic reaction to excipients of ointment and placebo.
7. Patient has hepatic insufficiency as defined by laboratory values outside the normal ranges
8. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless surgically sterile, who are unable or unwilling to use effective contraception.
9. Women who are pregnant or breastfeeding at baseline.
10. Patients with concurrent disease considered by the Investigator to be clinically significant in the context of the study including the use of high risk concomitant medications.
11. Patients who have a relevant history of clinically significant abnormalities on their screening blood tests. “Clinically significant” will be determined by the surgeon at the study site.
12. Patients who will be unavailable for the duration of the trial, deemed unable to comply with the requirements of the study protocol, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
13. Patients with evidence of significant improvement in the wound prior to intervention between the screening and baseline reviews

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Offsite allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 ratio for the two treatment groups using random block sizes with wound size <3cm as a stratification factor
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 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 26993 0
Turkey
State/province [1] 26993 0

Funding & Sponsors
Funding source category [1] 318782 0
Charities/Societies/Foundations
Name [1] 318782 0
St George Hospital Colorectal Research Fund
Country [1] 318782 0
Australia
Primary sponsor type
Individual
Name
David Z Lubowski - Sydney Colorectal Associates
Address
Country
Australia
Secondary sponsor category [1] 321220 0
None
Name [1] 321220 0
Address [1] 321220 0
Country [1] 321220 0
Other collaborator category [1] 283488 0
Commercial sector/Industry
Name [1] 283488 0
SLA Pharma
Address [1] 283488 0
Country [1] 283488 0
United Kingdom

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317389 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 317389 0
Ethics committee country [1] 317389 0
Australia
Date submitted for ethics approval [1] 317389 0
01/04/2025
Approval date [1] 317389 0
Ethics approval number [1] 317389 0

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

Contacts
Principal investigator
Name 140902 0
Prof David Z Lubowski
Address 140902 0
St George Hospital, Gray St, Kogarah, 2217 NSW
Country 140902 0
Australia
Phone 140902 0
+61 02 85661000
Fax 140902 0
Email 140902 0
[email protected]
Contact person for public queries
Name 140903 0
Ashley Jenkin
Address 140903 0
St George Hospital, Gray St, Kogarah, NSW 2217
Country 140903 0
Australia
Phone 140903 0
+61433335762
Fax 140903 0
Email 140903 0
[email protected]
Contact person for scientific queries
Name 140904 0
Ashley Jenkin
Address 140904 0
St George Hospital, Gray St, Kogarah, NSW 2217
Country 140904 0
Australia
Phone 140904 0
+61433335762
Fax 140904 0
Email 140904 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Protect patient confidentiality



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.