None listed
Conditions
Brief summary
This is a randomised, doubleblind, placebo controlled, multicenter study to be conducted across Australia, with an expected study duration of 8 weeks to determine the safety and efficacy of metronidazole ointment. Primary Objective • To determine whether treatment with metronidazole ointment increases healing in subjects presenting with non healing pilonidal disease. Method Patients with non healing pilonoidal sinus wounds will be randomised to one of two treatments or placebo. The wound healing will be measured using percentage improvement in wound size(rate of healing), "PUSH" score and time to healing recorded. Hypothesis Metronidazole ointment increases healing in subjects presenting with non healing pilonidal disease when compared to placebo. The research is a medical / clinical research project which studies the efficacy and safety metronidazole ointment in facilitating resolution of non healing pilonidal sinus.The study design is double blind placebo controlled, randomised control trial.
Interventions
Treatment Group A: Metronidazole 10% w/w ointment.
A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily for 6 weeks unless 100% healed earlier.
One dose contains approximately 70 mg metronidazole in a formulation of white soft paraffin. The investigator will demonstrate to the subject how to apply a 2.5 cm of ointment and dress the wound by applying the first dose and covering with a dry, gauze dressing which
Treatment Group A: Metronidazole 10% w/w ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily for 6 weeks unless 100% healed earlier. One dose contains approximately 70 mg metronidazole in a formulation of white soft paraffin. The investigator will demonstrate to the subject how to apply a 2.5 cm of ointment and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of ointment to ensure sufficient cover of the wound. Tubes of ointment will be weighed at each visit to measure dosage administered. Treatment Group B: Metronidazole 20% w/w ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily once daily for 6 weeks unless 100% healed earlier. One dose contains approximately 140 mg metronidazole in a formulation of white soft paraffin. The investigator will demonstrate to the subject how to apply a 2.5 cm of ointment and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of ointment to ensure sufficient cover of the wound. Tubes of ointment will be weighed at each visit to measure dosage administered.
Sponsors
David Lubowski
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must give written informed consent. 2. Male or female aged greater than or equal to 16 years. 3. Previous surgery for pilonidal disease and failure of healing for more than 6 weeks post-surgical excision of the pilonidal cyst/sinus; 4. Willingness to stop all other concomitant topical preparations at the site of pilonidal disease.
Exclusion criteria
1. Presence of non-drained abscess (abscess must have been drained more than 6 weeks prior to entry). 2. Patients who are due to undergo surgery related to pilonidal sinus. 3. Previous (in the last 2 weeks) or current treatment with any antibiotic based on medical history prior to screening. 4. Previous treatment with topical metronidazole for pilonidal sinus. 5. Known allergic reaction to metronidazole. 6. Known allergic reaction to excipients of IMP and placebo. 7. Subject is taking any prohibited medication (warfarin-type anticoagulants, fluorouracil, glucocorticoids, other topical preparations to the area of the wound, lithium, cyclosporin and disulfiram). 8. Experimental agents must have been discontinued at least 8 weeks prior to screening for a period equivalent to 5 half-lives of the agent (whichever is longer). 9. History of epilepsy or seizures. 10. Subject has hepatic insufficiency as defined by laboratory values outside the normal ranges. 11. Women who are pregnant or breastfeeding at baseline. 12. Subject with concurrent disease considered by the investigator to be clinically significant in the context of the study. 13. Patients who have clinically significant abnormalities on their screening blood tests. “Clinically significant” will be determined by the surgeon at the study site. 14. 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.
Outcome results
None listed