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Trial registered on ANZCTR


Registration number
ACTRN12624000169549
Ethics application status
Approved
Date submitted
15/01/2024
Date registered
23/02/2024
Date last updated
23/02/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Irrigation bottle size on nasal saline irrigation following sinus surgery.
Scientific title
Effect of Irrigation Bottle Size on Nasal Saline Irrigation Efficacy in Post-Sinus Surgery Patients: A Comparative Study.
Secondary ID [1] 311258 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Endoscopic Sinus Surgery
 332478 0
Chronic Rhinosinusitis 332479 0
Condition category
Condition code
Surgery 329170 329170 0 0
Other surgery
Respiratory 329472 329472 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

The intervention involves the use of a non-sterile, isotonic saline solution specifically designed for nasal irrigation. This solution aims to cleanse the nasal cavities, promoting the prevention of ear, nose, and throat (ENT) pathologies. By effectively clearing secretions, allergens, and irritants from the nasal passages, the intervention works to maintain a healthy nasal environment, hence expediting the post-surgery healing process. Participants will go on their irrigation 1 day post-surgery, meaning the intervention will start 1 day post-surgery. Participants in the study are instructed to self-administer the solution 4 times daily for a duration of 8 weeks. The control group will utilize a 200ml volume bottle, while the intervention group will employ a larger 400ml volume bottle during each administration. The entire volume, whether 200ml or 400ml, will be utilized in its entirety to cleanse both nasal cavities during each irrigation session. To monitor adherence and assess the impact of the intervention, patients will be provided with a daily diary to record their usage. These diary entries will be reviewed at each visit fortnightly to ensure consistency and gather valuable insights into the effectiveness of the nasal irrigation saline solution.
Intervention code [1] 327772 0
Treatment: Devices
Comparator / control treatment
Control will be using the standard commercially available 200ml bottle for each saline irrigation. Both the control and experimental groups will be using the same non-sterile, isotonic solution.
Control group
Dose comparison

Outcomes
Primary outcome [1] 337099 0
Post-operative recovery prognosis
Timepoint [1] 337099 0
Baseline (post-surgery) and every 2 weeks for 2 months (week 8 primary timepoint).
Secondary outcome [1] 430706 0
Visual pathological states within the nasal cavity
Timepoint [1] 430706 0
Baseline (post-surgery) and every 2 weeks for 2 months
Secondary outcome [2] 431811 0
Type C or B tympanometry
Timepoint [2] 431811 0
Baseline (post-surgery) and every 2 weeks for 2 months

Eligibility
Key inclusion criteria
Nasal Saline Irrigation indication following Post-FESS surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of frequent or active epistaxis, high risk of aspiration and incompletely healed facial trauma. Patient with significant craniofacial abnormalities.

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)
Participants will be randomised into two groups, each group using either a 200ml or 400ml bottle. Randomisation will be via sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/02/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315513 0
University
Name [1] 315513 0
Flinders University for Advanced Studies Project
Country [1] 315513 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Aspen Pharmacare Australia
Address
34-36 Chandos St, St leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 317596 0
Hospital
Name [1] 317596 0
Adelaide Specialist Group
Address [1] 317596 0
1 Flinders Drive, Bedford Park SA 5042
Country [1] 317596 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314417 0
Human Resources Ethics Committee Flinders University
Ethics committee address [1] 314417 0
Sturt Rd, Bedford Park SA 5042
Ethics committee country [1] 314417 0
Australia
Date submitted for ethics approval [1] 314417 0
25/07/2023
Approval date [1] 314417 0
20/11/2023
Ethics approval number [1] 314417 0
6224

Summary
Brief summary
The aim of this study is to compare the efficacy of 200ml and 400ml bottles used in nasal saline irrigation by conducting a randomised controlled trial in post-Functional Endoscopic Sinus Surgery (FESS) patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131502 0
Prof A. Simon Carney
Address 131502 0
Suite 200, Flinders Private Hospital, Bedford park SA 5042
Country 131502 0
Australia
Phone 131502 0
+61 8 8277 0288
Fax 131502 0
Email 131502 0
[email protected]
Contact person for public queries
Name 131503 0
Tracey O'Neil
Address 131503 0
Suite 200, Flinders Private Hospital, Bedford Park SA 5042
Country 131503 0
Australia
Phone 131503 0
+61 8 8277 0288
Fax 131503 0
Email 131503 0
[email protected]
Contact person for scientific queries
Name 131504 0
A. Simon Carney
Address 131504 0
Suite 200, Flinders Private Hospital, Bedford park SA 5042
Country 131504 0
Australia
Phone 131504 0
+61 8 8277 0288
Fax 131504 0
Email 131504 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21395Informed consent form    387111-(Uploaded-15-01-2024-15-03-54)-Study-related document.docx
21396Ethical approval    387111-(Uploaded-15-01-2024-15-04-52)-Study-related document.pdf
21398Study protocol    387111-(Uploaded-15-01-2024-15-30-36)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.