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Clinical Trials/ACTRN12621000381886
ACTRN12621000381886
Not yet recruiting
未知

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.

Gosford Hospital0 sites60 target enrollmentApril 6, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
chronic rhinosinusitis
Sponsor
Gosford Hospital
Enrollment
60
Status
Not yet recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 6, 2021
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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
  • \-Mucociliary disorder
  • \-History of Glaucoma
  • \-Unable to provide informed consent
  • \-Unable to commit to attending follow\-up appointments

Outcomes

Primary Outcomes

Not specified

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