Effect of novel drug with Chitodex gel on wound healing post endoscopic sinus surgery in the treatment of Chronic Rhinosinusitis (CRS)

Phase 1

Recruiting

• Conditions: Chronic Rhino-Sinusitis; Chronic recalcitrant sinusitis; Surgery - Other surgery; Infection - Other infectious diseases

• Registration Number: ACTRN12618000577213
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-16
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Participants who meet ALL of the following criteria will be offered inclusion in the study:
Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND
are over 18 years of age AND
are able to give written informed consent AND
are local and who will be returning to this centre for postoperative follow-up care AND
are indicated to undergo endoscopic sinus surgery and willing to return at 2, 6 & 12 weeks post-op.

Exclusion Criteria

1. allergy to shellfish
2. pregnant or breastfeeding
3. Hepatitis or blood disorders.
4.any drug allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stenosis of the sinus ostea as measured by a probe on endoscopic examination post operatively and followed up by endoscopic examinaion at 12 weeks. <br><br>12 week is the primary end point to measure outcomes.[Base line at time of surgery<br><br>12 weeks post surgery review ]