A multicenter study in China treated patients suffering from anal fistulas using a decellularized porcine small intestinal submucosa (SIS) plug

Patients were followed for six months to examine fistula closure, incontinence, and pain.

An anal fistula is an infected tunnel that develops between the skin and the muscular opening at the anus. Most anal fistulas are the result of an infection that starts in an anal gland, resulting in an abscess that eventually forms a tunnel under the skin and connects with the infected gland. Patients complain of constant leakage of flatus, mucus, or stool, as well as pain, and they are subject to the debilitating societal embarrassment of incontinence and odor.

A multicenter prospective clinical study was carried out in China that used the Biodesign^® Anal Fistula Plug to treat 81 patients suffering from chronic anal fistulas.¹ The study endpoints included the healing rate, recurrence within six months, rate of fecal incontinence, healing time, pain using a visual analog scale, and patient and doctor satisfaction.

Authors reported a six-month healing rate of 89.8% in the patients treated with Biodesign products, with an average healing time of 36 days. No severe pain or fecal incontinence was observed, and over 90% of patients and doctors were satisfied with the operative outcomes. No serious adverse events were reported.

The Biodesign Anal Fistula Plug is made from porcine SIS and has been on the market since 2007 showing variable rates of success. This paper demonstrates its continued success in treating patients with chronic anal fistulas, confirms the device’s safety profile, and confirms its role as a tool in the surgeon’s armamentarium to treat this debilitating and socially devastating disease.

¹ Chen ZW, Zheng Y, Zhao R, Wang ZJ. Treatment of anal fistula using a decellularized porcine small intestinal submucosa plug: A non-inferiority trial. Medicine. 2022;101(29):e29110.