Abstract
Objectives:
Evaluate the safety and efficacy of a novel, self-crosslinked hyaluronic acid (HA) hydrogel (PureRegen Gel Sinus) compared with carboxymethylcellulose (CMC) viscous foam (Stammberger SinuFoam) in promoting healing when applied following ethmoidectomy.
Methods:
Prospective, randomized, controlled, double-blinded clinical trial, with 4 surgeons operating in 2 community hospitals. Thirty patients with bilateral chronic rhinosinusitis underwent bilateral ethmoidectomy. Intraoperatively, each patient received 2 mL of HA hydrogel in one ethmoid cavity, and 2 mL of CMC contralaterally. The material applied within each ethmoid cavity was randomly assigned before surgery. A fifth independent surgeon, blinded to the material used to treat each ethmoid cavity, evaluated postoperative endoscopic video at 1 and 2 weeks for edema, crusting, and mucopurulence and at 6 and 12 weeks for re-mucosalization and scarring/synechiae. SinoNasal Outcome Test (SNOT-20) data were collected preoperatively and at each postoperative visit. A small sample of the cohort underwent endoscopic mucosal biopsy for histologic analysis.
Results:
Twenty-nine of 30 patients completed the protocol. The difference in edema, crusting, and mucopurulence at 1 and 2 weeks was not statistically significant; however, at 6 and 12 weeks, the HA hydrogel showed statistically significant reduction in synechiae formation (P < .05), with a trend toward superiority in re-mucosalization (P = .08). Histologic analysis of 6 subjects at 12 weeks also showed a trend toward a greater amount of regenerated cilia present in the HA hydrogel-treated ethmoid cavities (P = .22). The cohort showed a 75.18% improvement in SNOT-20 analysis.
Conclusions:
Self-crosslinked hyaluronic acid hydrogel provides superior wound healing to carboxymethylcellulose after ethmoidectomy.
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