drugset / Trial / NCT00461656
Povidone-iodine Antisepsis for Strabismus Surgery
Phase 4
Completed
70 enrolled
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabLaurentius Hospital Roermond · collabLeiden University Medical Center · collabLudwig-Maximilians - University of Munich · collabMartin-Luther-Universität Halle-Wittenberg · collabRotterdam Eye Hospital · collabUniversitair Ziekenhuis Brussel · collabUniversity Medicine Greifswald · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to compare the efficacy of 5 % vs. 1.25 % 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.
Timeline
- Start
- 2009-09
- Primary completion
- 2012-12
- Completion
- 2012-12
Publications
- Background Anderson RL, Vess RW, Carr JH, Bond WW, Panlilio AL, Favero MS. Investigations of intrinsic Pseudomonas cepacia contamination in commercially manufactured povidone-iodine. Infect Control Hosp Epidemiol. 1991 May;12(5):297-302. doi: 10.1086/646342.
- Background Apt L, Isenberg S, Yoshimori R, Paez JH. Chemical preparation of the eye in ophthalmic surgery. III. Effect of povidone-iodine on the conjunctiva. Arch Ophthalmol. 1984 May;102(5):728-9. doi: 10.1001/archopht.1984.01040030584025.
- Background Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61. doi: 10.1001/archopht.1997.01100150359008.
- Background Berkelman RL, Holland BW, Anderson RL. Increased bactericidal activity of dilute preparations of povidone-iodine solutions. J Clin Microbiol. 1982 Apr;15(4):635-9. doi: 10.1128/jcm.15.4.635-639.1982.
- Background Binder CA, Mino de Kaspar H, Klauss V, Kampik A. [Preoperative infection prophylaxis with 1% polyvidon-iodine solution based on the example of conjunctival staphylococci]. Ophthalmologe. 1999 Oct;96(10):663-7. doi: 10.1007/s003470050471. German.
- Background Caldwell DR, Kastl PR, Cook J, Simon J. Povidone-iodine: its efficacy as a preoperative conjunctival and periocular preparation. Ann Ophthalmol. 1984 Jun;16(6):577, 580.
- Background Carothers TS, Coats DK, McCreery KM, Rossman SN, Wilson P, Wu TG, Paysse EA. Quantification of incidental needle and suture contamination during strabismus surgery. Binocul Vis Strabismus Q. 2003;18(2):75-9.
- Background Ciulla TA, Starr MB, Masket S. Bacterial endophthalmitis prophylaxis for cataract surgery: an evidence-based update. Ophthalmology. 2002 Jan;109(1):13-24. doi: 10.1016/s0161-6420(01)00899-5.
- Background Davis GH, Finlayson N, Kemp R. Dilution of povidone-iodine. Med J Aust. 1985 Sep 30;143(7):321. doi: 10.5694/j.1326-5377.1985.tb123038.x. No abstract available.
- Background Dereklis DL, Bufidis TA, Tsiakiri EP, Palassopoulos SI. Preoperative ocular disinfection by the use of povidone-iodine 5%. Acta Ophthalmol (Copenh). 1994 Oct;72(5):627-30. doi: 10.1111/j.1755-3768.1994.tb07191.x.
- Background Ferguson AW, Scott JA, McGavigan J, Elton RA, McLean J, Schmidt U, Kelkar R, Dhillon B. Comparison of 5% povidone-iodine solution against 1% povidone-iodine solution in preoperative cataract surgery antisepsis: a prospective randomised double blind study. Br J Ophthalmol. 2003 Feb;87(2):163-7. doi: 10.1136/bjo.87.2.163.
- Background Grimes SR, Hollsten D, Nauschuetz WF, Whiddon RG, Trevino SB. Effect of povidone-iodine irrigation on the preoperative chemical preparation of the eye. Mil Med. 1992 Mar;157(3):111-3.
- Background Katosova LK. [The features of Haemophilus influenza and Streptococcus pneumoniae carriage and the comparative characteristics of strains isolated from healthy children and from patients with acute and chronic respiratory infections]. Zh Mikrobiol Epidemiol Immunobiol. 1994 Aug-Sep;Suppl 1:55-60. Russian.
- Background Khashu M, Chessex P, Chanoine JP. Iodine overload and severe hypothyroidism in a premature neonate. J Pediatr Surg. 2005 Feb;40(2):E1-4. doi: 10.1016/j.jpedsurg.2004.10.028.
- Background Lacey RW, Catto A. Action of povidone-iodine against methicillin-sensitive and -resistant cultures of Staphylococcus aureus. Postgrad Med J. 1993;69 Suppl 3(818):S78-83.
- Background Mino de Kaspar H, Chang RT, Singh K, Egbert PR, Blumenkranz MS, Ta CN. Prospective randomized comparison of 2 different methods of 5% povidone-iodine applications for anterior segment intraocular surgery. Arch Ophthalmol. 2005 Feb;123(2):161-5. doi: 10.1001/archopht.123.2.161.
- Background Olitsky SE, Vilardo M, Awner S, Reynolds JD. Needle sterility during strabismus surgery. J AAPOS. 1998 Jun;2(3):151-2. doi: 10.1016/s1091-8531(98)90006-4.
- Background Prince HN, Nonemaker WS, Norgard RC, Prince DL. Drug resistance studies with topical antiseptics. J Pharm Sci. 1978 Nov;67(11):1629-31. doi: 10.1002/jps.2600671134.
- Background Recchia FM, Baumal CR, Sivalingam A, Kleiner R, Duker JS, Vrabec TR. Endophthalmitis after pediatric strabismus surgery. Arch Ophthalmol. 2000 Jul;118(7):939-44.
- Background Roberts SM, Severin GA, Lavach JD. Antibacterial activity of dilute povidone-iodine solutions used for ocular surface disinfection in dogs. Am J Vet Res. 1986 Jun;47(6):1207-10.
- Background Singer TR, Isenberg SJ, Apt L. Conjunctival anaerobic and aerobic bacterial flora in paediatric versus adult subjects. Br J Ophthalmol. 1988 Jun;72(6):448-51. doi: 10.1136/bjo.72.6.448.
- Background Speaker MG, Milch FA, Shah MK, Eisner W, Kreiswirth BN. Role of external bacterial flora in the pathogenesis of acute postoperative endophthalmitis. Ophthalmology. 1991 May;98(5):639-49; discussion 650. doi: 10.1016/s0161-6420(91)32239-5.
- Background Speaker MG, Menikoff JA. Prophylaxis of endophthalmitis with topical povidone-iodine. Ophthalmology. 1991 Dec;98(12):1769-75. doi: 10.1016/s0161-6420(91)32052-9.
- Background Zamora JL. Chemical and microbiologic characteristics and toxicity of povidone-iodine solutions. Am J Surg. 1986 Mar;151(3):400-6. doi: 10.1016/0002-9610(86)90477-0.
- Background Zamora JL, Price MF, Chuang P, Gentry LO. Inhibition of povidone-iodine's bactericidal activity by common organic substances: an experimental study. Surgery. 1985 Jul;98(1):25-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Povidone-Iodine | Other / unclassified | 1.25 % | Other |
| Subject | Povidone-Iodine | Other / unclassified | 5 % | Other |