Effect of a dexamethasone Sinu‐Foam^TM middle meatal spacer on endoscopic sinus surgery outcomes: A randomized, double‐blind, placebo‐controlled trial

Abstract

This study demonstrated that an off-label drug-eluting middle-meatal spacer of dexamethasone and Sinu-Foam™ does not improve endoscopic outcomes in the early postoperative period following ESS when combined with postoperative saline irrigations and a short course of systemic steroids.

Post‐sinus surgery insertion of steroid‐eluting bioabsorbable intranasal devices: A systematic review

“…Four studies recruited patients listed for primary FESS, whereas the remaining articles included patients for either primary or revision FESS. Five articles recruited patients with bilateral CRS . Patients were commonly excluded if steroids were contraindicated or if patients had specified conditions such as a previous history of glaucoma or steroid‐dependent conditions.…”

“…This is a copolyetherester urethane foam and is Conformité Européenne (CE) approved but not currently FDA approved. Rudmik et al used Sinu‐foam (ArthroCare ENT; Austin, Texas) mixed with 4 mL dexamethasone (4 mg/mL) plus 4‐mL sterile water. This carboxymethylcellulose fiber is FDA approved.…”

“…All the above devices are bioabsorbable. The control devices used by the RCTs entailed nondrug‐eluting stents or use of saline in place of the steroid …”

“…Intraoperative steroids (IV dexamethasone) were administered to all but two patients by both Forwith et al and Murr et al, whereas the remaining studies did not comment upon this. Perioperative antibiotic regimens were specified by five of the seven articles …”

“…Postoperatively, oral and topical steroids were withheld in three studies . The 30‐mg prednisone 10‐day taper administered by Rudmik et al continued to day 3 post‐FESS. Dautremont et al began systemic steroids 1 week post‐FESS following endoscopic debridement.…”