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Trial registered on ANZCTR


Registration number
ACTRN12619000117112
Ethics application status
Approved
Date submitted
21/01/2019
Date registered
25/01/2019
Date last updated
11/02/2021
Date data sharing statement initially provided
25/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing post-sinus surgery symptoms of chronic sinusitis patients using Flo Sinus Care or Flo Kappa sinus rinses
Scientific title
Double blinded randomised controlled clinical trial comparing Flo Sinus Care with Flo Sinus Care containing carrageenan (Flo Kappa) for the management of symptoms in the immediate post-operative period in chronic sinusitis patients who have undergone sinus surgery
Secondary ID [1] 297045 0
Nil known
Universal Trial Number (UTN)
U1111-1226-5716
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 311035 0
Condition category
Condition code
Inflammatory and Immune System 309678 309678 0 0
Other inflammatory or immune system disorders
Respiratory 309834 309834 0 0
Other respiratory disorders / diseases
Surgery 309835 309835 0 0
Other surgery
Infection 309836 309836 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparing the immediate post-operative outcomes of patients after sinus surgery when they rinse with Flo Kappa sinus rinse kit, compared to the standard of care rinse kit (Flo Sinus Care).

The study will have two randomised double-blinded arms:
Control (standard of care rinse Flo Sinus Care), n=25
Flo Kappa rinse, n=25

After sinus surgery, patients will be randomly allocated standard of care sinus rinse kit (Flo Sinus Care) or modified rinse kit containing seaweed extract, kappa carrageenan (Flo Kappa). The kits consist of a clear plastic rinse bottle with nozzle and 1.9g powder sachets for reconstitution in 200mL boiled tepid water. Once reconstituted, the solution consists of sodium chloride (0.772%w/v), potassium chloride (0.042%w/v), calcium lactate pentahydrate (0.032%w/v), sodium bicarbonate (0.015%w/v), glucose anhydrous (0.085%w/v), and kappa carrageenan (0.12%w/v). This closely resembles Lactated Ringer's solution (plus kappa carrageenan). Isotonic pH of 7.2-8.0. No other chemicals or preservatives.

The participant will mix one sachet per one 200mL rinse bottle, and douche with one bottle (and one sachet) per side of the nose. Hence be using two bottles (and two sachets) per nasal rinse. This is repeated 4 times per day (i.e. 8 rinse bottle and 8 sachets per day) for the first 2 weeks, then 2 times per day (4 rinse bottles and 4 sachets per day) for another 10 weeks. The washing schedule will run for 12 weeks total.

The kit and sachets will be provided to the participant upon discharge from the hospital, with instructions for use. Neither the PI, follow-up doctors, or trial coordinators will know which sachets the participant is given, the treatments will be blinded by Pharmacy.

The participant is given verbal and written instruction on the intervention mode and frequency upon consent to the trial. Their adherence to the rinsing schedule will be checked at post-op visit 2 weeks, 6-8 weeks and 3 months (exit visit) by a Trial Coordinator. A Trial Coordinator will accompany the patient to these post-op visits, when they see their ENT doctor. During these standard of care appointments, questionnaire, a nasal swab and a mucus sample is collected along with sinus endoscopic score. Adverse side events and concomitant medications are also checked at each appointment.
Intervention code [1] 313410 0
Treatment: Other
Comparator / control treatment
Control (standard of care rinse Flo Sinus Care), n=25

The treatment arm of 25 participants will be compared to the control arm of 25 participants. The treatments are randomised and double-blinded, constituents of the non-medicated unlabelled sachets will either be as per the commercial product, Flo Sinus Care, or a modified version with the addition of kappa-carrageenan.

The participant will mix one sachet per one 200mL rinse bottle, and douche with one bottle (and one sachet) per side of the nose. Hence be using two bottles (and two sachets) per nasal rinse. This is repeated 4 times per day (i.e. 8 rinse bottle and 8 sachets per day) for the first 2 weeks, then 2 times per day (4 rinse bottles and 4 sachets per day) for another 10 weeks. The washing schedule will run for 12 weeks total.

The rinsing schedule is the general recommended schedule prescribed after sinus surgery for best results with healing and de-congestion.

Flo Sinus Care kits consist of a clear plastic rinse bottle with nozzle and 1.9g powder sachets for reconstitution in 200mL boiled tepid water. Once reconstituted, the solution consists of sodium chloride (0.772%w/v), potassium chloride (0.042%w/v), calcium lactate pentahydrate (0.032%w/v), sodium bicarbonate (0.015%w/v), and glucose anhydrous (0.085%w/v). This closely resembles Lactated Ringer's solution. Isotonic pH of 7.2-8.0. No other chemicals or preservatives.
Control group
Active

Outcomes
Primary outcome [1] 318767 0
Patient-reported symptom scores;
Sino-nasal outcomes test - 22 questions/symptoms, each graded 0-5
Timepoint [1] 318767 0
1) time of recruitment,
2) 2 weeks post-op/start of intervention,
3) 6-8 weeks post-op/start of intervention and
4) 3 months post-op/start of intervention/exit visit
Primary outcome [2] 318768 0
Patient-reported symptom scores;
Visual analogues scale - 7 questions/symptoms, each graded 0-10cm
Timepoint [2] 318768 0
1) time of recruitment,
2) 2 weeks post-op/start of intervention,
3) 6-8 weeks post-op/start of intervention and
4) 3 months post-op/start of intervention/exit visit
Primary outcome [3] 318769 0
Mucus cytokine measurements (measured by multiplex assay) for inflammatory marker;
IL-6,
Timepoint [3] 318769 0
1) time of recruitment,
2) 2 weeks post-op/start of intervention,
3) 6-8 weeks post-op/start of intervention and
4) 3 months post-op/start of intervention/exit visit
Secondary outcome [1] 365957 0
Patient-reported discomforts from the intervention.
At each post-operative follow-up visit, participants will be asked if they're experiencing ear pain or ear blockage. True/False answer to each.
Ear pain requires an reduction in pressure applied to the bottle when self-administering.
Ear blockage is a stop rule. Patient will stop the treatment.
Timepoint [1] 365957 0
1) 2 weeks post-op/start of intervention,
2) 6-8 weeks post-op/start of intervention and
3) 3 months post-op/start of intervention/exit visit
Secondary outcome [2] 366052 0
**Primary outcome 4**
Modified Lund-Kennedy Endoscopic Score (validated method)
Sinus appearance, 5 characteristics, graded 0-2 for each side. Total score out of 20.
Timepoint [2] 366052 0
1) time of recruitment,
2) 2 weeks post-op/start of intervention,
3) 6-8 weeks post-op/start of intervention and
4) 3 months post-op/start of intervention/exit visit
Secondary outcome [3] 366146 0
**Primary outcome 5**
Mucus cytokine measurements (measured by multiplex assay) for inflammatory marker;
IL-8
Timepoint [3] 366146 0
1) time of recruitment,
2) 2 weeks post-op/start of intervention,
3) 6-8 weeks post-op/start of intervention and
4) 3 months post-op/start of intervention/exit visit
Secondary outcome [4] 366147 0
**Primary outcome 6**
Mucus cytokine measurements (measured by multiplex assay) for inflammatory marker;
MMP9
Timepoint [4] 366147 0
1) time of recruitment,
2) 2 weeks post-op/start of intervention,
3) 6-8 weeks post-op/start of intervention and
4) 3 months post-op/start of intervention/exit visit
Secondary outcome [5] 366148 0
**Primary outcome 7**
Mucus cytokine measurements (measured by multiplex assay) for inflammatory marker;
INF-gamma
Timepoint [5] 366148 0
1) time of recruitment,
2) 2 weeks post-op/start of intervention,
3) 6-8 weeks post-op/start of intervention and
4) 3 months post-op/start of intervention/exit visit
Secondary outcome [6] 366149 0
**Primary outcome 8**
Mucus cytokine measurements (measured by multiplex assay) for inflammatory marker;
TNF-alpha
Timepoint [6] 366149 0
1) time of recruitment,
2) 2 weeks post-op/start of intervention,
3) 6-8 weeks post-op/start of intervention and
4) 3 months post-op/start of intervention/exit visit
Secondary outcome [7] 366150 0
**Primary outcome 9**
Mucus cytokine measurements (measured by multiplex assay) for inflammatory marker;
IL1-beta
Timepoint [7] 366150 0
1) time of recruitment,
2) 2 weeks post-op/start of intervention,
3) 6-8 weeks post-op/start of intervention and
4) 3 months post-op/start of intervention/exit visit
Secondary outcome [8] 391766 0
Rate of intranasal infection with S. aureus.
Timepoint [8] 391766 0
1) time of recruitment, 2) 2 weeks post-op/start of intervention, 3) 6-8 weeks post-op/start of intervention and 4) 3 months post-op/start of intervention/exit visit

Eligibility
Key inclusion criteria
Over 18 years old, a medical diagnosis of chronic rhinosinusitis (CRS) which is unresponsive to treatment and now requires surgery, procedure scheduled is a bilateral frontosphenoethmoidectomy (FH-FESS), immunocompetent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
under 18 years old, pregnant, breastfeeding, immunocompromised, immunosuppressed, a hypersensitivity to carrageenans, unable to provide informed written consent,

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed. Randomisation and allocation will be performed by The Queen Elizabeth Hospital Pharmacy. They normally issue the patients with their post-op nasal rinse kit so they will hold the blinded sachets and kits and randomly allocate to the trial participants after their operation, prior to discharge from the hospital.. Pharmacy will have a record of which patient was allocate to which arm and this would be partially revealed to the study team for data analysis, and fully revealed upon completion of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Research Randomiser to perform randomisation into permuted blocks 25 – randomised to either FLO sinus care sachets or K Carrageenan sachets.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Our study outcomes are numeric values. A partially blinded (arms defined but treatment not revealed) statistical analysis will be carried out; non-parametric tests such as Mann-Whitney U Test to compare the means of each group at each timepoint. A difference between the two arms of P,0.05 would be considered statistically significant. After data analysis is complete, the treatment arms would be revealed to assess if intervention was more effective than standard of care.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2020
Actual
18/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12970 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 25448 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 301614 0
Hospital
Name [1] 301614 0
The Queen Elizabeth Hospital, Department of Otolaryngology, Head and Neck Surgery
Country [1] 301614 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Alkis Psaltis
Address
Department of Otolaryngology, Head and Neck Surgery
The Queen Elizabeth Hospital
Tower Block 3C, 28 Woodville Road
Woodville South SA 5011
Country
Australia
Secondary sponsor category [1] 301440 0
None
Name [1] 301440 0
Address [1] 301440 0
Country [1] 301440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302340 0
Central Adelaide Local Health Network Human Research Ethics Committe (CALHN HREC)
Ethics committee address [1] 302340 0
Royal Adelaide Hospital
Clinical Trial Centre
Wayfinder 3D460.02
Level 3
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 302340 0
Australia
Date submitted for ethics approval [1] 302340 0
15/10/2018
Approval date [1] 302340 0
31/01/2019
Ethics approval number [1] 302340 0
HREC/18/CALHN/679

Summary
Brief summary
To determine whether adding kappa carrageenan to over-the-counter sinus rinse Flo Sinus Care can hasten the recovery after surgery when compared to the product alone. 50 participants will be recruited from The Queen Elizabeth Hospital who require endoscopic sinus surgery to treat chronic rhinosinusitis. Their randomised blinded treatment will be either Flo Sinus Care or Flo Kappa sachets for reconstitution and delivered as a sinus rinse for 12 weeks following surgery. We will assess each patient at time of surgery, 2 weeks, 6-8 weeks, and 3 months post-surgery using endoscopic scores and symptom scores, as well as an. intranasal bacterial swab and mucus sample at each time-point to measure inflammatory cytokines. Following on from our in vitro work with the above-mentioned treatments, we expect Flo Kappa to have a positive effect on healing and patient symptoms by way of reduced infection and inflammation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89882 0
A/Prof Alkis Psaltis
Address 89882 0
Department of Otolaryngology, Head and Neck Surgery
The Queen Elizabeth Hospital
Tower Block 3C
28 Woodville Road
Woodville South SA 5011
Country 89882 0
Australia
Phone 89882 0
+61 8 8222 6782
Fax 89882 0
Email 89882 0
[email protected]
Contact person for public queries
Name 89883 0
Anna Megow
Address 89883 0
Department of Otolaryngology, Head and Neck Surgery
The Queen Elizabeth Hospital
Tower Block 3C
28 Woodville Road
Woodville South SA 5011
Country 89883 0
Australia
Phone 89883 0
+61 412394002
Fax 89883 0
Email 89883 0
[email protected]
Contact person for scientific queries
Name 89884 0
Catherine Bennett
Address 89884 0
Department of Otolaryngology, Head and Neck Surgery
The Queen Elizabeth Hospital
Tower Block 3C
28 Woodville Road
Woodville South SA 5011
Country 89884 0
Australia
Phone 89884 0
+61 430546668
Fax 89884 0
Email 89884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will publish the results of the trial in a suitable scientific journal. This will not include individual participant data, summary tables and statistical analysis only


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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