Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461656
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2007-04-17
Brief Title:
Povidone-iodine Antisepsis for Strabismus Surgery
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Prospective Randomized Double-blind Comparison of 5 Against 125 Povidone-iodine Solution as Preoperative Antisepsis for Strabismus Surgery in Young Children
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASS
Brief Summary:
The purpose of this study is to compare the efficacy of 5 vs 125 povidone-iodine PI as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of endophthalmitis Given the low rate of endophthalmitis the conjunctival bacterial flora rate is used as surrogate marker to determine the effectiveness of topical PI in reducing or eliminating bacteria from the ocular surface at the time of the surgery Secondary objective is a reduction of the incidence of postoperative endophthalmitis after strabismus surgery in young children
Detailed Description:
Background Endophthalmitis after strabismus surgery in young children leads to blindness and loss of the affected eye It is caused by conjunctival bacteria PI solutions between 1 and 5 reduce the number of bacteria on the conjunctiva The concentration used varies widely among clinics from 1 to 5 In vitro studies have shown that PI is paradoxically more effective at lower concentration but in cataract surgery in elderly 1 PI has been shown to be less effective than 5 PI Dilution by tear fluid or binding of PI to proteins in tear fluid may lower its effectiveness Since endophthalmitis after strabismus surgery especially affects young children and the bacterial flora of the conjunctiva in children is different from that in adults the cataract PI study should be repeated in young children operated for strabismus
Objective To compare the efficacy of 5 vs 125 povidone-iodine PI as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of endophthalmitis Given the low rate of endophthalmitis the conjunctival bacterial flora rate is used as surrogate marker to determine the effectiveness of topical PI in reducing or eliminating bacteria from the ocular surface at the time of the surgery
Design The study is a multi-centre prospective randomized-controlled parallel-groups assessor-blind microbiological assessments investigator-initiated trial
Study population All children under 6 years of age attending the 15 participating clinics for routine strabismus surgery will be eligible for the study at the point that a strabismus operation is planned The clinics 5 Dutch 10 German will each recruit approximately 20 patients The minimum sample size is 2 x 100 patients
Intervention Diluted PI 125 or 5 will be prepared in a sterile fashion and distributed in single-use dispensers These will be coded for randomization Before initiation of surgery children randomized to the 5 PI group will have their conjunctival fornices irrigated with 5 ml PI 5 Children randomized to the 125 PI group will have their conjunctival fornices irrigated with 5 ml PI 125 Conjunctiva cultures for aerobic and anaerobic bacteria will be obtained 1 after general anesthesia has been established 2 5-10 min after PI irrigation 3 after reattachment of the eye muscles and 4 after closing the conjunctiva with sutures
Primary outcome The difference in the mean numbers of bacterial colony forming units CFUs from pre-irrigation l to post-irrigation with PI 2-4
Secondary outcome Iodine excretion after surgery assessed as urine iodine concentration per creatinine clearance
Postoperative erosion of the cornea and corneal oedema Both of these have been described as side-effects of PI use
Nature and extent of the burden and risks associated with participation
Risks are limited to the act of taking the four bacterial cultures as both 125 PI and 5 PI are approved preoperative antiseptic applications of PI and both are used rather indiscriminately by the university departments of ophthalmology participating in the study
Objective To compare the efficacy of 5 vs 125 povidone-iodine PI as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of endophthalmitis Given the low rate of endophthalmitis the conjunctival bacterial flora rate is used as surrogate marker to determine the effectiveness of topical PI in reducing or eliminating bacteria from the ocular surface at the time of the surgery
Design The study is a multi-centre prospective randomized-controlled parallel-groups assessor-blind microbiological assessments investigator-initiated trial
Study population All children under 6 years of age attending the 15 participating clinics for routine strabismus surgery will be eligible for the study at the point that a strabismus operation is planned The clinics 5 Dutch 10 German will each recruit approximately 20 patients The minimum sample size is 2 x 100 patients
Intervention Diluted PI 125 or 5 will be prepared in a sterile fashion and distributed in single-use dispensers These will be coded for randomization Before initiation of surgery children randomized to the 5 PI group will have their conjunctival fornices irrigated with 5 ml PI 5 Children randomized to the 125 PI group will have their conjunctival fornices irrigated with 5 ml PI 125 Conjunctiva cultures for aerobic and anaerobic bacteria will be obtained 1 after general anesthesia has been established 2 5-10 min after PI irrigation 3 after reattachment of the eye muscles and 4 after closing the conjunctiva with sutures
Primary outcome The difference in the mean numbers of bacterial colony forming units CFUs from pre-irrigation l to post-irrigation with PI 2-4
Secondary outcome Iodine excretion after surgery assessed as urine iodine concentration per creatinine clearance
Postoperative erosion of the cornea and corneal oedema Both of these have been described as side-effects of PI use
Nature and extent of the burden and risks associated with participation
Risks are limited to the act of taking the four bacterial cultures as both 125 PI and 5 PI are approved preoperative antiseptic applications of PI and both are used rather indiscriminately by the university departments of ophthalmology participating in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None