BACKGROUND: This study was designed to evaluate the safety and efficacy of a novel, self-cross-linked hyaluronic acid (HA) hydrogel compared with carboxymethylcellulose (CMC) viscous foam in promoting healing when applied after ethmoidectomy. A prospective, randomized, controlled, blinded clinical trial was performed. The study was performed by four surgeons operating in two community hospitals. METHODS:Thirty patients with bilateral chronic rhinosinusitis underwent bilateral total ethmoidectomy. Intraoperatively, each patient received 5 mL of HA hydrogel in one ethmoid cavity and 5 mL of CMC contralaterally. The material applied within each ethmoid cavity was randomly assigned before surgery. An 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 remucosalization and scarring/synechiae. Twenty-item Sino-Nasal Outcome Test SNOT-20 data were collected at each visit. A small sample underwent endoscopic mucosal biopsy. 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 both overall endoscopic grade (p < 0.05), as well as synechiae formation (p < 0.05), with a trend toward superiority in remucosalization (p = 0.08). Histological analysis of six subjects at 12 weeks showed a nonsignificant trend toward a greater amount of regenerated cilia present with the HA hydrogel (p = 0.23). SNOT-20 scores declined 78.8% from preoperative scores. CONCLUSION:Self-cross-linked HA hydrogel provides superior wound healing to CMC after ethmoidectomy.
RCT Entities:
BACKGROUND: This study was designed to evaluate the safety and efficacy of a novel, self-cross-linked hyaluronic acid (HA) hydrogel compared with carboxymethylcellulose (CMC) viscous foam in promoting healing when applied after ethmoidectomy. A prospective, randomized, controlled, blinded clinical trial was performed. The study was performed by four surgeons operating in two community hospitals. METHODS: Thirty patients with bilateral chronic rhinosinusitis underwent bilateral total ethmoidectomy. Intraoperatively, each patient received 5 mL of HA hydrogel in one ethmoid cavity and 5 mL of CMC contralaterally. The material applied within each ethmoid cavity was randomly assigned before surgery. An 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 remucosalization and scarring/synechiae. Twenty-item Sino-Nasal Outcome Test SNOT-20 data were collected at each visit. A small sample underwent endoscopic mucosal biopsy. 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 both overall endoscopic grade (p < 0.05), as well as synechiae formation (p < 0.05), with a trend toward superiority in remucosalization (p = 0.08). Histological analysis of six subjects at 12 weeks showed a nonsignificant trend toward a greater amount of regenerated cilia present with the HA hydrogel (p = 0.23). SNOT-20 scores declined 78.8% from preoperative scores. CONCLUSION: Self-cross-linked HA hydrogel provides superior wound healing to CMC after ethmoidectomy.