ANZCTR - Registration

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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]

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

Recurrent acute otitis media

Postoperative otorrhoea

Postoperative grommet blockage

Condition category

Condition code

Ear

Other ear disorders

Infection

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]

Prevention

Comparator / control treatment

Control: no drops/intervention will be given intraoperatively or postoperatively (double-blind arm)

Control group

Active

Outcomes

Primary outcome [1]

Otorrhoea/discharge through grommet through otoscopy

Timepoint [1]

6 weeks postoperatively

Primary outcome [2]

Ventilation tube occlusion via tympanometry (b-low tymps) + otoscopy

Timepoint [2]

6 weeks postoperatively

Secondary outcome [1]

Parent reported QoL measure (Otitis Media Outcome - 22)

Timepoint [1]

Baseline i.e. date of surgery and at 6 weeks postoperatively

Secondary outcome [2]

Parent reported presence of discharge (subjective)

Timepoint [2]

within the first 2 postoperative weeks

Secondary outcome [3]

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]

At time of operation

Secondary outcome [4]

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]

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?

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]

Casey Hospital - Berwick

Recruitment hospital [2]

Monash Children’s Hospital - Clayton

Recruitment postcode(s) [1]

3806 - Berwick

Recruitment postcode(s) [2]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Monash Health ENT Department

Address [1]

Monash Health ENT Department
Moorabbin Hospital
823-865 Centre Rd,
Bentleigh East VIC 3165

Country [1]

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]

University

Name [1]

Monash University

Address [1]

Monash University
Scenic Blvd & Wellington Road,
Clayton VIC 3800

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health HREC

Ethics committee address [1]

Human Ethics Committee
Monash Health (Monash Medical Centre)
246 Clayton Rd, 
Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/04/2018

Approval date [1]

25/05/2018

Ethics approval number [1]

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]

/AnzctrAttachments/375306-PreVenT-O - Patient Information and Consent Form.pdf (Participant information/consent)

Attachments [2]

/AnzctrAttachments/375306-RES-18-0000-175A HREC Review Only Final Approval Letter[9781].pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/375306-PreVenT-O - Study Protocol v1.1.pdf (Protocol)

Contacts

Principal investigator

Name

Dr Debra Phyland

Address

ENT Building
Moorabbin Hospital
P.O. Box 72, Rear
867 Centre Road
Bentleigh East VIC 3165

Country

Australia

Phone

+61 03 9928 8277

Fax

Debra.Phyland@monashhealth.org

Contact person for public queries

Name

Debra Phyland

Address

ENT Building
Moorabbin Hospital
P.O. Box 72, Rear
867 Centre Road
Bentleigh East VIC 3165

Country

Australia

Phone

+61 03 9928 8277

Fax

Debra.Phyland@monashhealth.org

Contact person for scientific queries

Name

Charles Giddings

Address

ENT Building
Moorabbin Hospital
P.O. Box 72, Rear
867 Centre Road
Bentleigh East VIC 3165

Country

Australia

Phone

+61 03 9928 8799

Fax

charles.giddings@monashhealth.org

No information has been provided regarding IPD availability

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
Embase	A randomised clinical trial of single or extended dosing ciprofloxacin versus no intervention for prevention of ventilation tube otorrhoea and obstruction (PreVenTO2).	2022	https://dx.doi.org/10.1111/coa.13887

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

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