Effect of microporous polysaccharide hemospheres (MPH) on bleeding after endoscopic sinus surgery: Randomized controlled study

doi:10.1016/j.otohns.2009.06.078

Otolaryngology - Head and Neck Surgery

Volume 141, Issue 3, September 2009, Pages 353-357

https://doi.org/10.1016/j.otohns.2009.06.078 Get rights and content

Abstract

Objectives

Absorbable hemostatic agents are commonly used after endoscopic sinus surgery (ESS). MPH (microporous polysaccharide hemospheres) is a novel hemostatic powder that is rapidly absorbed. The goal of this study was to examine the effects of MPH on bleeding after ESS.

Study Design

Randomized, controlled, single-blinded.

Setting

Tertiary university hospital.

Subjects and Methods

Patients undergoing bilateral (symmetric) ESS for CRS by the same surgeon were randomized to unilateral treatment with MPH at surgical conclusion. The untreated opposite side served as a control. All patients received standard postoperative management. Patients completed symptom diaries using visual analog scales (VAS, scored out of 100) at baseline and through postoperative day (POD) 30. Outcomes including bleeding, pain, obstruction, and nasal discharge were recorded separately for left and right sides.

Results

Forty patients (19 men, 21 women) with an average age of 48.3 years were included. There were no complications, and all patients were discharged home the same day. The mean bleeding score on POD one for MPH-treated sides was 22.5 vs 39.0 for untreated controls (mean reduction 16.5, P < 0.0001, 95% CI −23.2 to −9.7). The scores for bleeding at baseline and at all other post-treatment days were not significantly different (P > 0.05). There were no other significant differences between MPH-treated and control sides in any other variables measured.

Conclusion

The use of MPH after ESS results in significantly less bleeding in the early postoperative period with no increase in pain, obstruction, or nasal discharge. Patients treated with MPH follow a normal postoperative recovery otherwise.

Section snippets

Patient Selection

The study population consisted of patients undergoing bilateral, symmetrical ESS by the senior author (R.S.) using standard techniques for CRS with or without nasal polyps. All patients were diagnosed with CRS refractory to maximal medical therapy and had evidence of significant disease on post-therapy CT imaging. Patients meeting inclusion criteria were enrolled consecutively into this randomized, controlled, and blinded study. Patients with massive nasal polyposis (extending to the nasal

Results

Forty consecutive patients (19 men, 21 women) with a mean (SD) age of 48.3 (13.6) years (range, 21-79 years) comprised the study group. All patients completed symptom diaries for the entire study period. The demographics of the patient population are highlighted in Table 1. As shown, the mean (SD) preoperative Harvard CT stage was 3.1 (0.8); inter-quartile ranges were: 11 study patients in stage 2, 14 patients in stage 3, 15 patients in stage 4. Forty-five percent of the procedures were

Discussion

The choice of packing materials, or whether packing is used at all after ESS, is dependent upon the individual surgeon and the particular details of the case. Although the risk of significant hemorrhage following ESS is quite small,⁹ some degree of epistaxis is encountered postoperatively when no nasal packing is placed. The extent of bleeding that is to be expected following ESS has been shown to be significantly underestimated by patients.¹⁰ The “nuisance bleeding” experienced for a few days

Conclusion

MPH is a novel absorbable hemostatic agent with a unique mechanism of action and rapid clearance profile. The use of MPH after ESS results in significantly less bleeding in the early postoperative period with no increase in pain, obstruction, or nasal discharge. Patients treated with MPH follow a normal postoperative recovery otherwise.

Author Contributions

Jastin Antisdel, study design, data management, writer; Jackie West-Denning, data management, graph creation; Raj Sindwani, study design, data management, writer.

Disclosures

Competing interests: This project was funded in part by an unrestricted educational grant from Medafor, Inc (Minneapolis, MN, manufacturer of MPH). The company had no role in the study design, data analysis, interpretation, or the decision to publish the findings of this study.

Sponsorships: None.

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Original research–sinonasal disordersEffect of microporous polysaccharide hemospheres (MPH) on bleeding after endoscopic sinus surgery: Randomized controlled study

Abstract

Objectives

Study Design

Setting

Subjects and Methods

Results

Conclusion

Section snippets

Patient Selection

Results

Discussion

Conclusion

Author Contributions

Disclosures

Eur J Vasc Endovasc Surg

J Urol

Otolaryngol Head Neck Surg

Otolaryngol Clin North Am

Otolaryngol Head Neck Surg

Nasal packing after routine nasal surgery: is it justified?

J Laryngol Otol

A scientific review of middle meatal packing/stents

Am J Rhinol

Original research–sinonasal disorders
Effect of microporous polysaccharide hemospheres (MPH) on bleeding after endoscopic sinus surgery: Randomized controlled study