title: Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening.
abstract: To assess safety and efficacy of a steroid-releasing implant in improving surgical outcomes when placed in the frontal sinus opening (FSO) following endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS).
  
  
  
  Prospective, multicenter, randomized, blinded trial using an intrapatient control design.
  
  
  
  Eighty adult (≥ 18 years) CRS patients who underwent successful bilateral frontal sinusotomy were randomized to receive a steroid-releasing implant in one FSO, whereas the contralateral control side received no implant. All patients received standard postoperative care. Endoscopic evaluations recorded at 30-days postendoscopic sinus surgery (ESS) were graded real time by clinical investigators and by an independent, blinded sinus surgeon to assess the need for postoperative interventions in the FSO.
  
  
  
  Implants were successfully placed in all 80 frontal sinuses, resulting in 100% implant delivery success. At 30-days post-ESS, steroid-releasing implants provided a statistically significant (P = 0.0070) reduction in the need for postoperative interventions compared to surgery alone by an independent reviewer, representing 38% relative reduction. Clinical investigators reported statistically significant reduction in this measure at 30 days (P < 0.0001) and 90 days (P = 0.0129). Clinical investigators also reported a 55.6% reduction in the need for oral steroid interventions (P = 0.0015), 75% reduction in the need for surgical interventions (P = 0.0225), 16.7% reduction in inflammation score, 54.3% reduction in restenosis rate (P = 0.0002), and 32.2% greater diameter of FSO (P < 0.0001) on treated sides compared to control at 30 days. No implant-related adverse events were reported.
  
  
  
  This study demonstrates the efficacy of steroid-releasing implants in improving outcomes of frontal sinus surgery.
  
  
  
  1b. Laryngoscope, 126:2659-2664, 2016.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Oregon Health Sciences University, Portland, Oregon, U.S.A.
authors.forename: Timothy L
authors.initials: TL
authors.lastname: Smith
authors.affiliation: Department of Surgery and Neurosurgery, George Washington Medical Faculty Associates, Washington, DC, U.S.A.
authors.forename: Ameet
authors.initials: A
authors.lastname: Singh
authors.affiliation: Department of Otorhinolaryngology, McGovern Medical School at the University of Texas Health Science Center of Houston, Houston, Texas, U.S.A.
authors.forename: Amber
authors.initials: A
authors.lastname: Luong
authors.affiliation: Sacramento ENT, Roseville, California, U.S.A.
authors.forename: Randall A
authors.initials: RA
authors.lastname: Ow
authors.affiliation: Advanced ENT and Allergy, Louisville, Kentucky, U.S.A.
authors.forename: Steven D
authors.initials: SD
authors.lastname: Shotts
authors.affiliation: Providence St. Vincent Medical Center, Portland, Oregon, U.S.A.
authors.forename: Nathan B
authors.initials: NB
authors.lastname: Sautter
authors.affiliation: Divisions of Rhinology and Endoscopic Sinus-Skull Base Surgery and Allergy, Eastern Virginia Medical School, Norfolk, Virginia, U.S.A.
authors.forename: Joseph K
authors.initials: JK
authors.lastname: Han
authors.affiliation: Intersect ENT, Menlo Park, California, U.S.A.
authors.forename: James
authors.initials: J
authors.lastname: Stambaugh
authors.affiliation: Intersect ENT, Menlo Park, California, U.S.A.
authors.forename: Aarthi
authors.initials: A
authors.lastname: Raman
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D004343:Drug Implants; D004724:Endoscopy; D005260:Female; D005626:Frontal Sinus; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate / Q000008:administration & dosage*; D011182:Postoperative Care; D011446:Prospective Studies; D012220:Rhinitis / Q000601:surgery*; D016037:Single-Blind Method; D012852:Sinusitis / Q000601:surgery*; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D000893:Anti-Inflammatory Agents; D004343:Drug Implants; D000068656:Mometasone Furoate
keywords: Corticosteroid; absorbable implant; frontal sinus; frontal sinusotomy; functional endoscopic sinus surgery (FESS); inflammation; mometasone furoate; polyposis