None listed
Conditions
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
Interventions
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
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
Sponsors
David Z Lubowski - Sydney Colorectal Associates
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed