Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening

Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.26140. Epub 2016 Jul 1.

Abstract

Objectives/hypothesis: 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).

Study design: Prospective, multicenter, randomized, blinded trial using an intrapatient control design.

Methods: 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.

Results: 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.

Conclusion: This study demonstrates the efficacy of steroid-releasing implants in improving outcomes of frontal sinus surgery.

Level of evidence: 1b. Laryngoscope, 126:2659-2664, 2016.

Trial registration: ClinicalTrials.gov NCT02266810.

Keywords: Corticosteroid; absorbable implant; frontal sinus; frontal sinusotomy; functional endoscopic sinus surgery (FESS); inflammation; mometasone furoate; polyposis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorbable Implants*
  • Adult
  • Anti-Inflammatory Agents / administration & dosage*
  • Drug Implants
  • Endoscopy
  • Female
  • Frontal Sinus*
  • Humans
  • Male
  • Middle Aged
  • Mometasone Furoate / administration & dosage*
  • Postoperative Care
  • Prospective Studies
  • Rhinitis / surgery*
  • Single-Blind Method
  • Sinusitis / surgery*
  • Wound Healing / drug effects*

Substances

  • Anti-Inflammatory Agents
  • Drug Implants
  • Mometasone Furoate

Associated data

  • ClinicalTrials.gov/NCT02266810