Management of post-ethmoidectomy crust formation: randomized single-blind clinical trial comparing pressurized seawater versus antiseptic/mucolytic saline.

This study compared the efficacy of mechanical nasal lavages with pressurized seawater versus nasal irrigations with saline plus benzododecinium (antiseptic) plus oleosorbate (mucolytic). Twenty patients agreed to participate in a randomized, single-blind clinical trial. All patients underwent endoscopic endonasal ethmoidectomy for nasal polyps. The packing was removed after 48 h and patients were asked to start the same day nasal lavages three times a day. Clinical evaluations were performed: (1) by weighing residual nasal crusts and secretions after 21 +/- 2 days; and (2) by using visual analogue scales to daily record symptom scores. Data are presented as mean +/- SEM. T-test statistics for two independent groups were applied. The mean residual crust and secretion weights were 1,756 +/- 688 mg and 1,033 +/- 422 mg in the pressurized seawater group, 932 +/- 414 mg and 1,222 +/- 435 mg in the antiseptic-mucolytic saline group. No statistical differences were found. Sample size calculations showed that 100 subjects in each group would be necessary to confirm a 700-mg reduction in residual crusts in the antiseptic/mucolytic saline group (power = 0.80; two-sided type-I error = 0.05). Daily symptom score curves were similar in both groups and allowed us to give a description of post-operative complaints. The role of antiseptic, mucolytic and mechanical lavages in preventing post-ethmoidectomy crust formation is discussed.

RCT Entities:   Population Interventions Outcomes