title: Clinical evaluation of a fully synthetic middle meatal stent for safety and tolerability.
abstract: OBJECTIVE
  To evaluate the safety and tolerability of a novel, fully synthetic, poly-urethane middle meatal dressing after endoscopic sinus surgery (ESS).
  
  
  METHODS
  Case series with planned data collection.
  
  
  METHODS
  Tertiary care medical facility.
  
  
  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.
authors.affiliation: Department of Otolaryngology-Head & Neck Surgery, St Elizabeth's Medical Center, Brighton, MA 02135, USA. peter.catalano@caritaschristi.org
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Catalano
authors.forename: Spencer
authors.initials: S
authors.lastname: Payne
authors.forename: Mark
authors.initials: M
authors.lastname: Thong
mesh_terms: D001458:Bandages; D001672:Biocompatible Materials / Q000627:therapeutic use; D002908:Chronic Disease; D004724:Endoscopy; D004867:Equipment Design; D006801:Humans; D011140:Polyurethanes; D011474:Prosthesis Design; D012220:Rhinitis / Q000601:surgery*; D012852:Sinusitis / Q000601:surgery*; D015607:Stents; D013530:Surgical Wound Infection / Q000453:epidemiology
chemical_list: D001672:Biocompatible Materials; D011140:Polyurethanes