Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000187347
Ethics application status
Approved
Date submitted
3/04/2008
Date registered
11/04/2008
Date last updated
1/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Survival of bacteria on the ocular surface following double application of povidone-iodine before cataract surgery
Scientific title
Survival of bacteria on the ocular surface following double application of povidone-iodine before cataract surgery
Secondary ID [1] 292071 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endophthalmitis 2988 0
Condition category
Condition code
Eye 3138 3138 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Two applications of 5% povidone-iodine to the eye and surrounding skin prior to phacoemulsification cataract surgery. All patients will receive 5mL of povidone-iodine 5% solution applied via sterile swab and forceps to the conjunctival sac, lashes and periocular skin of the operative eye at time of the periorbital anaesthetic block as well as in theatre approximately 15 minutes later. Note: This is part of the standard procedure for the surgery, and NOT a new intervention.
Intervention code [1] 2769 0
Not applicable
Comparator / control treatment
No control group - all patients receive 2 applications of povidone-iodine.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4064 0
Bacterial recontamination of the conjunctiva following the first application of povidone iodine. This will be assessed by comparing cultures of swabs taken after the first application of povidone-iodine, with cultures of swabs taken just prior to the second application of povidone-iodine (about 15 minutes later). Bacterial recontamination could occur during this time. Each swab specimen will be put in a 1mL container of normal saline, from which 300 microlitres (100 microlitres, 3 times separately) is removed by automatic pipette and plated on blood agar (2 plates) as well as chocolate agar (1 plate). Each plate has 100 microlitres of broth applied to it. These plates will be sent for incubation within three hours of specimen collection. Specimens plated on blood agar will be incubated at 35 degrees centigrade a) aerobically, and b) anaerobically. The specimen on chocolate agar will be incubated at 35 degrees centigrade in 5% CO2.
Timepoint [1] 4064 0
Cultures assessed at three days
Secondary outcome [1] 6835 0
No bacterial contamination following the first application of povidone-iodine. Swabs are cultured and assessed as in primary outcome.
Timepoint [1] 6835 0
Cultures assessed at three days

Eligibility
Key inclusion criteria
Unilateral phacoemulsification surgery for cataract
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to povidone-iodine, active ocular infection, antibiotic therapy in preceding three weeks

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/04/2008
Actual
28/04/2008
Date of last participant enrolment
Anticipated
Actual
23/05/2008
Date of last data collection
Anticipated
Actual
26/05/2008
Sample size
Target
72
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8203 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 8204 0
Stirling District Hospital - Stirling
Recruitment postcode(s) [1] 16262 0
5011 - Woodville
Recruitment postcode(s) [2] 16263 0
5152 - Stirling

Funding & Sponsors
Funding source category [1] 3257 0
Hospital
Name [1] 3257 0
The Queen Elizabeth Hospital
Country [1] 3257 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
28 Woodville Rd, Woodville South, SA 5011
Country
Australia
Secondary sponsor category [1] 2935 0
None
Name [1] 2935 0
Address [1] 2935 0
Country [1] 2935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5239 0
Ethics of Human Research Committee (TQEH)
Ethics committee address [1] 5239 0
28 Woodville Rd, Woodville South, SA 5011
Ethics committee country [1] 5239 0
Australia
Date submitted for ethics approval [1] 5239 0
07/04/2008
Approval date [1] 5239 0
14/04/2008
Ethics approval number [1] 5239 0

Summary
Brief summary
To assess the incidence of positive preoperative conjunctival cultures with two (at time of periorbital anaesthetic block and in theatre approximately 15 minutes later) in comparison with one (at time of the anaesthetic block only) applications of 5% povidone-iodine solution to the operative eye before phacoemulsification cataract surgery.

Ultimately to assess whether microbial recontamination occurs after the initial application of povidone-iodine, and thus whether two applications of povidone-iodine are necessary in order to reduce the rate of positive preoperative conjunctival cultures.
Trial website
Trial related presentations / publications
Stranz C, Fraenkel G, Butcher A, Esterman A, Goggin M. Survival of bacteria on the ocular surface following double application of povidone-iodine before cataract surgery. Eye (Lond) 2011; 25 (11): 1423-1428.
Public notes

Contacts
Principal investigator
Name 28484 0
Dr Conrad Stranz
Address 28484 0
c/o
East Adelaide Medical Centre
50 Hutt Street
Adelaide SA 5000
Country 28484 0
Australia
Phone 28484 0
+61 8 8210 9488
Fax 28484 0
Email 28484 0
conrad.stranz@gmail.com
Contact person for public queries
Name 11641 0
Dr Conrad Stranz
Address 11641 0
c/o
East Adelaide Medical Centre
50 Hutt Street
Adelaide SA 5000
Country 11641 0
Australia
Phone 11641 0
+61 8 8210 9488
Fax 11641 0
Email 11641 0
conrad.stranz@gmail.com
Contact person for scientific queries
Name 2569 0
Dr Conrad Stranz
Address 2569 0
c/o
East Adelaide Medical Centre
50 Hutt Street
Adelaide SA 5000
Country 2569 0
Australia
Phone 2569 0
+61 8 8210 9488
Fax 2569 0
Email 2569 0
conrad.stranz@gmail.com

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No Supporting Document Provided



Results publications and other study-related documents

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