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Trial registered on ANZCTR
Registration number
ACTRN12618000577213
Ethics application status
Approved
Date submitted
16/03/2018
Date registered
16/04/2018
Date last updated
16/04/2019
Date data sharing statement initially provided
16/04/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effect of novel drug with Chitodex gel on wound healing post endoscopic sinus surgery in the treatment of Chronic Rhinosinusitis (CRS)
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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)
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Secondary ID [1]
294350
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TGA: CT-2017-CTN-04279-1 v1
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Universal Trial Number (UTN)
U1111-1211-0391
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Trial acronym
CDG CT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Rhino-Sinusitis
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Chronic recalcitrant sinusitis
307073
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Condition category
Condition code
Surgery
306182
306182
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0
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Other surgery
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Infection
306255
306255
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
300652
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Treatment: Surgery
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Intervention code [2]
300653
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Treatment: Devices
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Intervention code [3]
300694
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Treatment: Drugs
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Comparator / control treatment
The trial has 2 sets of patients;
1. FESS only group-and One side of the sinuses is control ( routine saline nasal douching)
2.FESS + drill out- 10 participants controls (saline nasal douching would used as treatment).
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
305190
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Timepoint [1]
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Base line at time of surgery
12 weeks post surgery review
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Secondary outcome [1]
344459
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Secondary outcomes will be eradication of infection indicated by a negative microbiology swab of the sinuses.
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Assessment method [1]
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Timepoint [1]
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12 weeks post surgery review nasal swab culture
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Secondary outcome [2]
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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%
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Assessment method [2]
345057
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Timepoint [2]
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12 weeks
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Secondary outcome [3]
345502
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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
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Assessment method [3]
345502
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Timepoint [3]
345502
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0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative
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Secondary outcome [4]
345503
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Crusting(0-2) on endoscopic examination
0-Absent
1-,Mild,
2-Severe
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Assessment method [4]
345503
0
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Timepoint [4]
345503
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0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative
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Secondary outcome [5]
345504
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Granulations(0-3) on endoscopic examination
0-absent
1-mild
2-moderate
3-severe
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Assessment method [5]
345504
0
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Timepoint [5]
345504
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0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative
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Secondary outcome [6]
345505
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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
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Assessment method [6]
345505
0
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Timepoint [6]
345505
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0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative
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Secondary outcome [7]
345506
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Bleeding: 0 is no bleeding, 10 is bleeding requiring re-operation to control it
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Assessment method [7]
345506
0
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Timepoint [7]
345506
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0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative
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Secondary outcome [8]
345507
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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.
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Assessment method [8]
345507
0
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Timepoint [8]
345507
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0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative
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Secondary outcome [9]
345508
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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.
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Assessment method [9]
345508
0
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Timepoint [9]
345508
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0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative
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Secondary outcome [10]
345509
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Sense of smell: 0 is no smell ability at all, 10 is best smell ability.
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Assessment method [10]
345509
0
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Timepoint [10]
345509
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0 weeks, 2 weeks post post operative, 6 weeks post operative and 12 weeks post operative
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Secondary outcome [11]
345510
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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).
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Assessment method [11]
345510
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Timepoint [11]
345510
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0 weeks and 12 weeks post operative
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. allergy to shellfish
2. pregnant or breastfeeding
3. Hepatitis or blood disorders.
4.any drug allergy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified, block randomization procedure will be employed to ensure equal numbers of patients who underwent ESS and ESS+frontal drill out in each of the treatment groups. This will employ a 2 (procedure) by 3 (treatment groups) stratification design with 10 patients randomized to each of the six cells. Further stratification will randomise each group of 10 patients so that 5 receive the procedure on the left nostril and 5 receive it on the right nostril. This is to ensure that site of procedure (left or right nostril ) does not confound the results. A similar group of 10 patients undergoing FESS + drill out would be recruited as controls where only saline would used as treatment
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Power calculations were based on the requirement that effects be assessed at the 5% alpha level with 80% statistical power. The outcomes are measured based on the wound healing in the sinus openings made during surgery. We have determined that a clinically meaningful difference between the two closest treatment groups would be a minimal difference of 3 mm2 area in the frontal ostial size at 12 weeks post-surgery. Based on available data, we would expect the standard deviation to be approximately ½ the magnitude of the mean difference (i.e.: 1.5). In this study, observations over time may be correlated due to clustering within nostril and patient. This would result in an under estimate of the variance with a consequent increase in the risk of a type 1 error. We have inflated the estimated standard deviation by a factor of 1.5 (i.e.: 1.5 * 1.5 = 2.25) to account for this. Following this adjustment, a sample of 1 patients per treatment arm would be required.
Analysis: Continuous measures will be summarized as means with standard deviations or medians with inter-quartile range as appropriate. Categorical measures will be summarized with counts and percentages. The descriptive statistics will be reported with stratification by treatment arm. Differences over time will be assessed using linear mixed effects models with participants treated as a random factor. All tests will be two-tailed and assessed at the 5% alpha level.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
14/02/2018
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Date of last participant enrolment
Anticipated
1/09/2022
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Actual
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Date of last data collection
Anticipated
30/11/2022
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Actual
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Sample size
Target
90
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Queen Elizabeth Hospital - Woodville
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Recruitment postcode(s) [1]
22078
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5011 - Woodville
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Funding & Sponsors
Funding source category [1]
298992
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University
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Name [1]
298992
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The University of Adelaide
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Address [1]
298992
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Adelaide, South Australia
5005 Australia
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Country [1]
298992
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Australia
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Primary sponsor type
University
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Name
The University of Adelaide
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Address
Adelaide, South Australia
5005 Australia
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Country
Australia
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Secondary sponsor category [1]
298216
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None
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Name [1]
298216
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Address [1]
298216
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Country [1]
298216
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299921
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CALHN Human Research Ethics Committee
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Ethics committee address [1]
299921
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Level 3, Roma Mitchell House 136 North Terrace Adelaide, South Australia, 5000
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Ethics committee country [1]
299921
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Australia
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Date submitted for ethics approval [1]
299921
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24/10/2017
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Approval date [1]
299921
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21/12/2017
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Ethics approval number [1]
299921
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HREC/17/TQEH/245
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Summary
Brief summary
This research project is testing a new treatment for chronic rhinosinusitis by the use of a Chitosan-Dextran (Chitodex) gel mixed with medications to see if there is improved healing after sinus surgery and less infection. Chronic rhinosinusitis affects approximately 15% of the general population and is characterised by sinusitis symptoms persisting for more than 3 months. Patients who do not respond adequately to oral and topical steroids, antibiotics and nasal lavage require surgical management. The surgical procedure is termed endoscopic sinus surgery, and involves removing oedematous mucosa, pus and debris, as well as clearance of bony walls within the sinonasal cavity to open up blocked sinuses. Participants will receive the standard hospital information sheet about the sinus surgery, and will sign the standard hospital consent form for the sinus surgery. Purpose: The purpose of this research project is testing in sinus surgery whether adding two new antimicrobial agents (Deferiprone and Gallium-Protoporphyrin ) to a locally developed dissolvable nasal dressing (Chitodex gel) will improve the anti-microbial and wound-healing effects of Chitodex gel after sinus surgery compared to Chitodex alone. Procedure and Treatment: Under endoscopic guidance, each participant will have a sinus swab performed prior to surgery and then undergo the planned sinus surgery- Endoscopic sinus surgery (ESS) or ESS with frontal drill out At the end of the procedure, each participant will receive 10 ml of gel (Chitodex or Chitodex+ Deferiprone or Chitodex+ Deferiprone+ Gallium-Protoporphyrin) into one side of each of the three sinuses and the untreated side would be referred to as the control and receive routine standard of care. If the surgery is meant to produce a larger frontal sinus cavity (ESS with frontal drillout) 20 ml of gel would be applied or 20 ml of saline if you are in the control group. Post-operative care will proceed as per standard care after sinus surgery. Participants will return to the outpatient department 2 weeks, 6 weeks and 12 weeks after the surgery for post-operative review. During each visit we would perform a sinus swab and an endoscopic video recording of the sinuses. The recorded video examination will then be scored by an independent clinician, unaware of your treatment, for infection (pus), oedema, granulation tissue, and crusting using a standardised scoring scales.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
81994
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Prof Peter John Wormald
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Address
81994
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Department Of ENT, Head Neck & Skull Base Surgery
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
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Country
81994
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Australia
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Phone
81994
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+61882227158
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Fax
81994
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+61882227419
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Email
81994
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[email protected]
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Contact person for public queries
Name
81995
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Rajan Sundaresan Vediappan
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Address
81995
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Department Of ENT, Head Neck & Skull Base Surgery
The Queen Elizabeth Hospital/Basil Hetzel Institute
28 Woodville Road
Woodville South
SA 5011
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Country
81995
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Australia
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Phone
81995
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+61882227158
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Fax
81995
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61882227419
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Email
81995
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[email protected]
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Contact person for scientific queries
Name
81996
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Rajan Sundaresan Vediappan
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Address
81996
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Department Of ENT, Head Neck & Skull Base Surgery
The Queen Elizabeth Hospital/Basil Hetzel Institute
28 Woodville Road
Woodville South
SA 5011
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Country
81996
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Australia
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Phone
81996
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+61882227158
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Fax
81996
0
61882227419
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Email
81996
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Pt privacy issues
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
Tackling superbugs in their slime castles: innovative approaches against antimicrobial-resistant biofilm infections
2019
https://doi.org/10.1071/ma19049
Embase
Chitogel following endoscopic sinus surgery promotes a healthy microbiome and reduces postoperative infections.
2022
https://dx.doi.org/10.1002/alr.23001
N.B. These documents automatically identified may not have been verified by the study sponsor.
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