Comparison of the efficacy and safety of steroid-impregnated self-crosslinked hyaluronic acid (PureRegen®) and steroid-impregnated bioabsorbable polyurethane foam (Nasopore®) in adults undergoing functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis (CRS): a randomised controlled trial.

Not Applicable

• Conditions: chronic rhinosinusitis; Surgery - Other surgery; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12621000381886
• Lead Sponsor: Gosford Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-06
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1)CT Lund-Mackay score was greater and equal to 1, AND
2)Minimum trial of at least eight weeks’ duration of a topical intranasal corticosteroid, AND
3)Short course of systemic corticosteroid (CRSwNP) OR either a short-course of a broad spectrum / culture-directed systemic antibiotic OR the use of a prolonged course of systemic low-dose anti-inflammatory antibiotic (CRSsNP)
4)Post-medical treatment total SNOT-22 score greater than or equal to 20.

Exclusion Criteria

-Immunodeficiency
-Cystic fibrosis
-Rhinologic granulomatous disease
-Use of oral/nasal steroids from 30 days preoperatively to 30 days postoperatively
-Previous sinus surgery
-Aspirin intolerance
-Asthma
-Mucociliary disorder
-History of Glaucoma
-Unable to provide informed consent
-Unable to commit to attending follow-up appointments

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is determining which device confers the greatest endoscopic post-FESS benefit at 2 weeks, 1 month, 2 months and 3 months via validated scoring systems such as PeriOperative Sinus Endoscopy Score and Lund-Kennedy Scores off recorded endoscopic video at clinic followups[2 weeks, 1 month, 2 months and 3 months post operatively.]

Secondary Outcome Measures

Name	Time	Method
Ascertain whether there are any systemic effects of steroid-impregnated Nasopore or steroid-impregnated PureRegen.<br><br>This composite secondary outcome will be assessed with serial measurement of early morning serum ACTH and serum cortisol (preoperatively, day 7, 14 and 28 postoperatively).[Preoperatively (baseline), day 7, 14 and 28 postoperatively.];To assess whether there are any ocular effects (i.e. intraocular hypertension) of steroid-impregnated Nasopore and steroid-impregnated PureRegen via serial tonometry measurements (preoperatively, day 1 postoperatively, day 7, 14 and 28 postoperatively).[1 week, 2 weeks, 4 weeks postoperatively];Comparison of subjective post-operative benefit between steroid-impregnated Nasopore and steroid-impregnated PureRegen via serial SinoNasal Outcome Test (SNOT-22) patient reported symptom questionnaire.[Preoperatively, 2 weeks, 1 month, 2 months, 3 months postoperatively.]