Double-Blinded Randomised Controlled Trial Evaluating the Efficacy of Chitogel Versus PureRegen Gel on Postoperative Outcomes from Endoscopic Sinus Surgery.

Abstract

ObjectivesThis study aims to compare Chitogel^® with topical corticosteroid versus PureRegen^® gel on wound healing and postoperative outcomes in the treatment of chronic rhinosinusitis.MethodsA double-blinded randomized controlled trial was performed with patients undergoing functional endoscopic sinus surgery who were prospectively recruited and randomized to receive Chitogel with triamcinolone to one side of the sinuses and PureRegen to the contralateral sinuses. The patients underwent endoscopic follow-up at 2, 6, and 12 weeks postoperatively. Patient factors including age, gender, smoking status, comorbidities (reflux, allergy, and asthma), and disease specific factor (chronic rhinosinusitis phenotype) were collected. Sinus ostial measurements, adhesions, mucopurulent discharge, edema, crusting, and granulation were assessed. A visual analogue scale questionnaire on quality of life was assessed in each follow-up appointment.ResultsA total of 40 patients were randomized. At 12 weeks, Chitogel had a 10.7 mm² reduction in frontal sinus ostium area compared to 15 mm² in the PureRegen group; Chitogel had a 2.2 mm² increase in maxillary ostium area compared to 0.1 mm² in the PureRegen group; Chitogel had a 27.6 mm² reduction in area of the sinus ostium compared to 28.7 mm² in the PureRegen group. However, these differences were not statistically significant. The difference between the two groups when analysing adhesion, mucopurulent discharge, mucosal oedema, crusting, granulation, and phenotype was not statistically significant. Patient self-directed grading on quality of life was not statistically significant.ConclusionBoth Chitogel with triamcinolone and PureRegen have demonstrated to be great options to prevent adhesion, stenosis, and optimize healing. There were no clinical and statistical differences between both products in wound healing and postoperative outcomes in the treatment of chronic rhinosinusitis.