Factibility and security study of the PICS-AF™ plug for the treatment of cryptoglandular anal fistula.

INTRODUCTION

The PICS-AF™ (Curaseal Inc.) device is a new plug made of collagen that has a retention system in the internal orifice. This pilot study was designed to assess both the feasibility and safety of this plug in the treatment of trans-sphincteric anal fístulas.

METHODS

A total of 44 patients (34 men), with a mean age of 54.68±7.3, with trans-sphincteric anal fístulas were included in the study; 34 of them were analyzed. All patients were examined according to a strict preoperative protocol and until 6 months after surgery. The feasibility of the procedure and the adverse events were analyzed.

RESULTS

Finally, 34 patients were operated on, and in 30 of them the plug was used. Therefore, the feasibility was calculated at 88%. There was a total of 16 adverse events, 4recorded as not related (3 mild and one moderate) and 12 related to the procedure or to the device implanted. Of these, 5were mild, 5moderate and 2severe. The majority of the events reported were related to proctalgia (4 patients) or infection at the implant site (4 patients).

CONCLUSIONS

The present study indicates that the new collagen plug can be placed effectively and with an acceptable complication rate.