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Trial registered on ANZCTR


Registration number
ACTRN12618001082291
Ethics application status
Approved
Date submitted
11/06/2018
Date registered
28/06/2018
Date last updated
28/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing paediatric middle ear Ventilation Tube Obstruction with topical ciprofloxacin (PreVenT-O) : a randomised controlled trial
Scientific title
Preventing paediatric middle ear Ventilation Tube Obstruction with topical ciprofloxacin (PreVenT-O) : a randomised controlled trial
Secondary ID [1] 295165 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PreVenT-O
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis media with effusion 308284 0
Recurrent acute otitis media 308285 0
Postoperative otorrhoea 308286 0
Postoperative grommet blockage 308287 0
Condition category
Condition code
Ear 307295 307295 0 0
Other ear disorders
Infection 307371 307371 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: 5 drops of Ciprofloxacin 0.3% topical ear drops intraoperatively (double-blind arm) This is done by a research nurse.
Arm 2: 5 drops of Ciprofloxacin 0.3% topical ear drops intraoperatively + 5 drops of Ciprofloxacin 0.3% topical ear drops twice a day for 5 days postoperatively, given by the parent (assessor-blind arm) Bottles are returned on the postoperative visit. They will also be questioned about their compliance.

Intervention code [1] 301502 0
Prevention
Comparator / control treatment
Control: no drops/intervention will be given intraoperatively or postoperatively (double-blind arm)
Control group
Active

Outcomes
Primary outcome [1] 306248 0
Otorrhoea/discharge through grommet through otoscopy
Timepoint [1] 306248 0
6 weeks postoperatively
Primary outcome [2] 306249 0
Ventilation tube occlusion via tympanometry (b-low tymps) + otoscopy
Timepoint [2] 306249 0
6 weeks postoperatively
Secondary outcome [1] 347988 0
Parent reported QoL measure (Otitis Media Outcome - 22)
Timepoint [1] 347988 0
Baseline i.e. date of surgery and at 6 weeks postoperatively
Secondary outcome [2] 347989 0
Parent reported presence of discharge (subjective)
Timepoint [2] 347989 0
within the first 2 postoperative weeks
Secondary outcome [3] 348574 0
Presence of middle ear effusion and effusion type via otomicroscopy assessed by surgeon
Serous effusion - more than 50% thin clear/straw-coloured fluid
Mucoid - more than 50% thick clear/straw-coloured fluid
Purulent - pus-containing effusion
No effusion - no effusion
Timepoint [3] 348574 0
At time of operation
Secondary outcome [4] 348575 0
Presence or absence of Tympanic Membrane Bleeding via otomicroscopy assessed by surgeon
No/minimal bleeding - drops of blood not requiring suction at myringotomy incision site
Moderate bleeding - blood requiring suction covering up to 50% of Tympanic Membrane
Severe bleeding - blood requiring suction covering more than 50% of Tympanic Membrane
Timepoint [4] 348575 0
At time of operation

Eligibility
Key inclusion criteria
Undergoing bilateral grommet surgery for either:
- recurrent acute otitis media (greater than 4 episodes of AOM in 6 months, or greater than 6 in 12 months)
- chronic otitis media with effusion (middle ear effusion lasting for more than 3 months)

Minimum age
No limit
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- allergy to quinolone based antibiotics
- recent use of antibiotics (within 7 days of surgery)
- failure to gain consent to participate in the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by shuffling of identical sealed opaque envelopes 4 times
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Efficacy
Statistical methods / analysis
The comparisons of interest are between Arm 1 and control as well as Arm 2 and control.
For our power analysis we assumed alpha of 0.05, beta of 0.2.
Our assumed incidence of otorrhoea/blockage for Arm 1 and 2 was 4.5% and for control was 12%.
Using a two tailed test, we determined a sample size of 621 was needed (207 in each arm). As we will be evaluating outcomes by ear, this equates to 104 participants in each arm.
Accounting for a 15% attrition rate, this equates to 120 participants per arm. Totaling 360 participants.

Demographic information of patients (age, gender, daycare attendance, pets, severity of disease, smoke exposure, parental worry score) and Intraoperative findings (Presence and absence of middle ear effusion and type, tympanic membrane bleeding) will also be assessed and used for subgroup analysis.

Our comparisons will use chi-square test for binary primary outcomes.
ANOVA or non-parametric equivalent for Qol differences between postop and baseline
Logistic regressions for correlation of baseline and intraoperative risk-factors with primary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
Date of last participant enrolment
Anticipated
30/05/2019
Actual
Date of last data collection
Anticipated
11/07/2019
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11122 0
Casey Hospital - Berwick
Recruitment hospital [2] 11123 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 22939 0
3168 - Clayton
Recruitment postcode(s) [2] 22938 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 299743 0
Hospital
Name [1] 299743 0
Monash Health ENT Department
Country [1] 299743 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Monash Health ENT Department
Moorabbin Hospital
823-865 Centre Rd,
Bentleigh East VIC 3165
Country
Australia
Secondary sponsor category [1] 299080 0
University
Name [1] 299080 0
Monash University
Address [1] 299080 0
Monash University
Scenic Blvd & Wellington Road,
Clayton VIC 3800
Country [1] 299080 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300634 0
Monash Health HREC
Ethics committee address [1] 300634 0
Human Ethics Committee
Monash Health (Monash Medical Centre)
246 Clayton Rd,
Clayton VIC 3168
Ethics committee country [1] 300634 0
Australia
Date submitted for ethics approval [1] 300634 0
26/04/2018
Approval date [1] 300634 0
25/05/2018
Ethics approval number [1] 300634 0
HREC/18/MonH/182

Summary
Brief summary
Research aims: The aims of this trial is to assess the efficacy and rationale for routine topical antibiotic (Ciprofloxacin) for the prevention of grommet obstruction and otorrhoea in grommet surgery (myringotomy and ventilation tube
placement)

Hypothesis:
That a single intraoperative dose of topical ciprofloxacin is as effective as a 5-day postoperative course for prophylaxis of two post-operative complications of paediatric grommet surgery when compared against no prophylaxis.

That factors such as age, indication for surgery, number of previous grommets and intraoperative middle ear status are correlated with developing post-operative complications.

That there is a significant patient reported quality of life benefit in prophylaxis compared to no prophylaxis.

Participants: 360 paediatric patients (17 and under), who are undergoing bilateral myringotomy and ventilation
tube placement, with a diagnosis of otitis media with effusion for at least 3 months or recurrent acute otitis media.
Methods: 360 participants will be randomised to three groups. (1) Control group, receiving no intervention. (2)
Single dose group, receiving one intraoperative dose of topical ciprofloxacin and no post­operative doses. (3)
Multi dose group, receiving one intraoperative dose of ciprofloxacin and a 5­day post­operative course of topical
ciprofloxacin (2 doses daily)
Measured outcomes:
(1) Incidence of ventilation tube obstruction at 6 weeks diagnosed by otoscopy and tympanometry.   
(2) Incidence of ventilation tube otorrhoea at 2 weeks and 6 weeks by otoscopy.
(3) Difference in validated disease specific QOL(OMO­22) at date of surgery and 6 weeks. 
(4) Difference in audiometry pre­op and 6 weeks post­op.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2767 2767 0 0
/AnzctrAttachments/375306-PreVenT-O - Patient Information and Consent Form.pdf (Participant information/consent)
Attachments [2] 2768 2768 0 0
/AnzctrAttachments/375306-RES-18-0000-175A HREC Review Only Final Approval Letter[9781].pdf (Ethics approval)
Attachments [3] 2769 2769 0 0
/AnzctrAttachments/375306-PreVenT-O - Study Protocol v1.1.pdf (Protocol)

Contacts
Principal investigator
Name 84282 0
Dr Debra Phyland
Address 84282 0
ENT Building
Moorabbin Hospital
P.O. Box 72, Rear
867 Centre Road
Bentleigh East VIC 3165
Country 84282 0
Australia
Phone 84282 0
+61 03 9928 8277
Fax 84282 0
Email 84282 0
Debra.Phyland@monashhealth.org
Contact person for public queries
Name 84283 0
Dr Debra Phyland
Address 84283 0
ENT Building
Moorabbin Hospital
P.O. Box 72, Rear
867 Centre Road
Bentleigh East VIC 3165
Country 84283 0
Australia
Phone 84283 0
+61 03 9928 8277
Fax 84283 0
Email 84283 0
Debra.Phyland@monashhealth.org
Contact person for scientific queries
Name 84284 0
Dr Charles Giddings
Address 84284 0
ENT Building
Moorabbin Hospital
P.O. Box 72, Rear
867 Centre Road
Bentleigh East VIC 3165
Country 84284 0
Australia
Phone 84284 0
+61 03 9928 8799
Fax 84284 0
Email 84284 0
charles.giddings@monashhealth.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23644Study protocol https://www.anzctr.org.au/AnzctrAttachments/375306-PreVenT-O%20-%20Study%20Protocol%20v1.1.pdf 
23645Informed consent form https://www.anzctr.org.au/AnzctrAttachments/375306-PreVenT-O%20-%20Patient%20Information%20and%20Consent%20Form.pdf 
23646Ethical approval  debra.phyland@monashhealth.org

Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised clinical trial of single or extended dosing ciprofloxacin versus no intervention for prevention of ventilation tube otorrhoea and obstruction (PreVenTO2).2022https://dx.doi.org/10.1111/coa.13887
N.B. These documents automatically identified may not have been verified by the study sponsor.