The efficacy of hemostatic powder for chronic rhinosinusitis in endoscopic sinus surgery: a prospective, randomised, controlled and single blinded clinical trial / 中华耳鼻咽喉头颈外科杂志

ABSTRACT

Objective: To study the efficacy and patient comfort of absorbable hemostatic powder after endoscopic sinus surgery (ESS). Methods: A total of 21 (17 males, 4 females) patients with an average age of 42(ranging from 18 to 65) underwent bilateral ESS for chronic rhinosinusitis(CRS) in Beijing Tongren Hospital, Capital Medical University between October 2015 and July 2019 were enrolled to compare the effect of absorbable hemostasis powder with Nasopore using an intrapatient control design. A randomized controlled trial was conducted in the left and right nasal cavities of the same patient. If hemostatic powder was applied in the experiment nasal cavity, the Nasopore was applied in the control nasal cavity. The mean preoperative sinus computed tomography (CT) score was 6.25. All patients competed for symptom diaries using a visual analog scale (VAS, score out of 10) at baseline, through 1, 7, 14 and 30 days. Outcomes including bleeding, facial pain, nasal obstruction, nasal discharges using VAS were recorded separately for both sides. Postoperative endoscopic scores were also investigated. SPSS 22 and Graphpad prism 8.0 statistical softwares were used for the analysis. Paired t-test or nonparametric test was used between the test side and the control side. The difference was statistically significant (P<0.05). Results: The bleeding score and total nasal symptom VAS scores at postoperative days (POD) 1, 7, 14 and 30 were not significantly different(t=1.341, 0.552, 0.631, 0.158, all P>0.05;t=0.944, 1.471, 1.612, 2.251, all P>0.05). There was no significant difference between absorbable hemostasis powder and Nasopore side on POD 1, 7, 14 and 30 in terms of each nasal symptom VAS scores(all P>0.05). On POD 1, 7 and 14, the packing material degeneration scores of the absorbable hemostasis powder side were significantly lower than those of the Nasopore side [(1.33±0.21)vs(2.00±0.00),(0.38±0.18) vs (1.95±0.22), 0 vs (1.80±0.13), all P<0.01]. There were significant differences between absorbable hemostasis powder and Nasopore side on POD 1, 7, 14 and 30 in terms of endoscopic scores (edema, crusting, discharges, scar, polyps and material degeneration, t=3.07, 7.00, 6.41, 2.69, all P<0.05). Conclusions: The absorbable hemostasis powder and Nasopore has similar postoperative hemostasis effect. The absorbable hemostasis powder is rapidly cleared and without negative effects on mucosal wound healing 14 days postoperatively.