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

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12618000577213
• Date of registration: 16/04/2018
• Prospective Registration: No
• Primary sponsor: The University of Adelaide
• Public title: Effect of novel drug with Chitodex gel on wound healing post endoscopic sinus surgery in the treatment of Chronic Rhinosinusitis (CRS)
• Scientific title: Chitosan-dextran (Chitodex) gel with and without Deferiprone and Gallium-Protoporphyrin-wound healing and post operative outcomes in the treatment of Chronic Rhinosinusitis (CRS)
• Date of first enrolment: 14/02/2018
• Target sample size: 90
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12618000577213.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: A/Prof Rajan Sundaresan Vediappan

• Name: A/Prof Rajan Sundaresan Vediappan

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Surgery - Other surgery

Chronic Rhino-Sinusitis;Chronic recalcitrant sinusitis;
Chronic Rhino-Sinusitis
Chronic recalcitrant sinusitis

Infection - Other infectious diseases

Intervention(s)

FESS(Functional Endoscopic Sinus Surgery) alone (consisting 4 arms)

Arm 1- Dissolvable nasal dressing (Chitodex gel: CD-gel) alone- 10 ml of CD gel applied in the operated sinus, only once immediately at the end of surgery.

Arm 2-CD gel with the iron chelator Deferiprone(20mM/ml-)10 ml of CD gel with Deferiporone applied in the operated sinus, only once immediately at the end of surgery.

Arm 3- CD gel with the iron chelator Deferiprone(20mM/ml and the antibacterial agent Gallium-Protoporphyrin(250 µg/ml) -.10 ml of CD gel applied in the operated sinus, only once immediately at the end of surgery

Arm 4 - CD gel + GaPP the antibacterial agent Gallium-Protoporphyrin(250 µg/ml) - 10 ml of CD gel with drug applied in the operated sinus, only once immediately at the end of surgery

in FESS + drill out ( consisting 5 arms) 20 ml of CD gel applied in the frontal sinus, only once immediately at the end of surgery just as 4 arms of FESS group and

Arm 5- Saline control

All patients will undergo complete blood counts , Serum Iron levels and Liver funtion test before application. Post-operatively the serum drug levels of Deferiporone & Gallium Protoporphyrin willbe evaluated at 2 hrs, 6 hrs and 2 weeks . They will also be watched for development of any symptoms of photosensitivity.

Primary Outcome(s)

Stenosis of the sinus ostea as measured by a probe on endoscopic examination post operatively and followed up by endoscopic examinaion at 12 weeks.

12 week is the primary end point to measure outcomes.[Base line at time of surgery

12 weeks post surgery review ]

Secondary Outcome(s)

ORDINAL SCALE MEASUREMENT: Adhesion of Middle turbinate to medial wall on right and left side in percentages  as assesed by endoscopic examination:
0%,
1-25%,
26-50% or
more than 50%[ 12 weeks]

Sense of smell: 0 is no smell ability at all, 10 is best smell ability.[0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative]

Crusting(0-2) on endoscopic examination
0-Absent
1-,Mild,
2-Severe[0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative]

Bleeding: 0 is no bleeding, 10 is bleeding requiring re-operation to control it
[0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative]

Patient Chronic Sinusitis symptom severeity is measured subjectively using the SNOTT 22 score (a standardised questionare consisteing of 22 questions which describe the symptoms of a patients in scale of 0 to 5 , o being no symptoms and 5 being severe symptoms).[0 weeks and 12 weeks post operative]

Mucosal odema( 0-3) on endoscopic examination
0 being no visible mucosal odema
1 mild mucosal odema without oblitartion of the ethmoid cavity
2-severe mucosal odema oblitrating most of the ethmoid
3-Frank polyposis[ 0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative]

Nasal Secretion/throat drip: 0 is no nasal secretions, 10 is copious secretions with con-stant nasal dripping.
Throat drip: 0 is no nasal secretions, 10 is copious secretions with constant nasal drip-ping.

[0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative]

Secondary outcomes will be eradication of infection indicated by a negative microbiology swab of the sinuses.[12 weeks post surgery review nasal swab culture]

Granulations(0-3) on endoscopic examination
0-absent
1-mild
2-moderate
3-severe[0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative]

Nasal Obstruction: 0 is a perfect airway which is very easy to breathe through, 10 is completely blocked with no air movement through that side.
[0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative]

Visual analouge scale(subjective score done by the patients on right and left side seperately)
Facial Pain/Discomfort: 0 is no pain or discomfort, 10 is the worst pain theyhave ever experienced
[0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative]

Secondary ID(s)

TGA: CT-2017-CTN-04279-1 v1

Source(s) of Monetary Support

The University of Adelaide

Ethics review

Status: Approved
Approval date:
Contact:

CALHN Human Research Ethics Committee