Evaluating the effects of metronidazole ointment for non-healing pilonidal sinus wounds in adults

Exclusion Criteria13

• Presence of undrained abscess (abscess must have been drained at least 6 weeks prior to entry), tunnels or pits.
• Patients who are due to undergo surgery related to pilonidal sinus.
• Previous use (in the last 2 weeks) or current treatment with any antibiotic. To be determined by medical history.
• Previous treatment with topical metronidazole for pilonidal sinus.
• Known allergic reaction to metronidazole.
• Known allergic reaction to excipients of ointment and placebo.
• Patient has hepatic insufficiency as defined by laboratory values outside the normal ranges
• 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.
• Women who are pregnant or breastfeeding at baseline.
• 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.
• 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.
• 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.
• Patients with evidence of significant improvement in the wound prior to intervention between the screening and baseline reviews