Ortem, a formulation of metronidazole is currently under clinical trial to study the effect on pain relief, reduction of discharge and improves healing rates in cases of pilonidal sinus.
Metronidazole is not just an anti-microbial agent, it also has anti-inflammatory activity, and can inhibit the reactive oxygen species generated by neutrophils. Decreasing the inflammation and infection associated with pilonidal sinus, in conjunction with good wound management, can reduce pain and discharge, and promote healing.
Pilonidal disease presents as a subcutaneous cyst or abscess that commonly arises in hair follicles and occurs, principally, in the natal cleft of the sacrococcygeal area. A familial history of pilonidal disease and obesity are recognised risk factors for the condition, which occurs most frequently in the second to fourth decades of life. Although the aetiology is not entirely clear, the presence of hair and other debris leads to a foreign body reaction, resulting in inflammation, infection and painful swelling.
Our study is conducted on patients with a confirmed diagnosis of a non-healing wound following surgical intervention for pilonidal sinus, defined as being at least 6 weeks after surgery following primary intervention or post incision and drainage of an abscess following secondary intervention, and will be randomised.
69 subjects will be randomised in a 1:1:1 ratio; metronidazole ointment (10% and 20%), or placebo ointment, with once daily dosing for the treatment period.