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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
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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
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Secondary ID [1]
314395
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NCT04273997
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
This study is the Australian arm of NCT04273997
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Health condition
Health condition(s) or problem(s) studied:
pilonidal sinus
337178
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Condition category
Condition code
Skin
333779
333779
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0
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Other skin conditions
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Surgery
333594
333594
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
330868
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Treatment: Drugs
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Comparator / control treatment
Placebo ointment (contains titanium dioxide and white soft paraffin)
The placebo ointment does not contain any metronidazole
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Proportion of patients with complete wound healing by week 8
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Assessment method [1]
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Clinical assessment + pressure ulcer scale for healing
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Timepoint [1]
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8 weeks post commencement of treatment
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Secondary outcome [1]
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Evaluate the safety of metronidazole ointment in the treatment of non-healing pilonidal sinus wounds
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Assessment method [1]
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Adverse effects will be assessed via fortnightly clinical assessment and patient-reported diary Topical metronidazole is less likely than systemic delivery to cause side effects, but may be associated with minor skin irritation or gastrointestinal upset. It may interact with certain medications (including warfarin, lithium, and cyclosporin) and patients on these medications will be excluded from the trial, The impact of topical metronidazole on pregnant or breast-feeding women and their offspring is unknown and women who are expecting, breast feeding, or unwilling to use contraception will be excluded from the trial
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Timepoint [1]
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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
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Secondary outcome [2]
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Determine the effects of metronidazole in promoting partial healing
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Assessment method [2]
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healing rate, clinical assessment and pressure ulcer scale of healing score
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Timepoint [2]
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week 8 post treatment commencement
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Secondary outcome [3]
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Determine effect of topical metronidazole on the time course of wound healing
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Assessment method [3]
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clinical assessment and pressure ulcer scale of healing score
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Timepoint [3]
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week 8 post treatment commencement
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Secondary outcome [4]
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Determine the effects of metronidazole on the patient’s global impression of improvement
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Assessment method [4]
446652
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Patient’s Global Impression of Improvement (PGI-I) is a one question subjective assessment of whether the patient feels their condition has been improved by the trial ointment or not. It is a well validated tool in many surgical and non-surgical research contexts
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Timepoint [4]
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week 8 post commencement of treatment
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Offsite allocation
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/05/2025
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Actual
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Date of last participant enrolment
Anticipated
30/04/2026
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment outside Australia
Country [1]
26993
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Turkey
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State/province [1]
26993
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Funding & Sponsors
Funding source category [1]
318782
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Charities/Societies/Foundations
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Name [1]
318782
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St George Hospital Colorectal Research Fund
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Address [1]
318782
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Country [1]
318782
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Australia
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Primary sponsor type
Individual
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Name
David Z Lubowski - Sydney Colorectal Associates
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Address
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Country
Australia
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Secondary sponsor category [1]
321220
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None
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Name [1]
321220
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Address [1]
321220
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Country [1]
321220
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Other collaborator category [1]
283488
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Commercial sector/Industry
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Name [1]
283488
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SLA Pharma
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Address [1]
283488
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Country [1]
283488
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United Kingdom
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317389
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South Eastern Sydney Local Health District HREC
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Ethics committee address [1]
317389
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https://www.seslhd.health.nsw.gov.au/services-clinics/directory/research-home/ethics
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Ethics committee country [1]
317389
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Australia
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Date submitted for ethics approval [1]
317389
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01/04/2025
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Approval date [1]
317389
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Ethics approval number [1]
317389
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Summary
Brief summary
The goal of this study is to determine whether topical metronidazole ointment works to improve healing rates and achieve complete healing without causing discomfort or side effects for non-healing pilonidal wounds. Based on a previous pilot study, we hypothesize that 10% topical metronidazole will be better than placebo in achieving these outcomes
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof David Z Lubowski
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Address
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St George Hospital, Gray St, Kogarah, 2217 NSW
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Country
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Australia
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Phone
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+61 02 85661000
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Fax
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Email
140902
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[email protected]
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Contact person for public queries
Name
140903
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Ashley Jenkin
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Address
140903
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St George Hospital, Gray St, Kogarah, NSW 2217
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Country
140903
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Australia
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Phone
140903
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+61433335762
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Fax
140903
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Email
140903
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[email protected]
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Contact person for scientific queries
Name
140904
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Ashley Jenkin
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Address
140904
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St George Hospital, Gray St, Kogarah, NSW 2217
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Country
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Australia
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Phone
140904
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+61433335762
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Fax
140904
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Email
140904
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[email protected]
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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.
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