Clinical evaluation of a fully synthetic middle meatal stent for safety and tolerability.

OBJECTIVE

To evaluate the safety and tolerability of a novel, fully synthetic, poly-urethane middle meatal dressing after endoscopic sinus surgery (ESS).

STUDY

DESIGN

Case series with planned data collection.

SETTING

Tertiary care medical facility.

SUBJECTS AND

METHODS

In total, 104 patients with medically refractory chronic rhinosinusitis were treated with patient-appropriate ESS and a poly-urethane sponge placed into their middle meatus at the end of operation, giving a total of 173 middle meatus stent placements. Patients were then assessed immediately postoperatively and 2, 6, 12, and 16 weeks after surgery for adverse systemic or local reaction to the stent and the incidence of postoperative infections.

RESULTS

There was no pain or allergic reaction encountered with this new material. There were 11 middle meati (6.4%; 95% confidence interval, 3.2%-11.1%) with postoperative infection at 2 weeks follow-up. There were no other stent-related local reactions (ie, excessive bleeding, middle meatal synechia, or granulation) up to 16 weeks postoperatively. Residual middle meatal stent material was either absent or negligible at 2 weeks postoperatively.

CONCLUSIONS

This first fully synthetic poly-urethane middle meatal dressing used during ESS demonstrated excellent biocompatibility and safety. The incidence of localized postoperative infection was also low.