Suture Contamination Rate in Adjustable Suture Strabismus Surgery
NCT ID: NCT02424357
Last Updated: 2017-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2015-07-31
2016-02-29
Brief Summary
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2. To identify bacterial species and antibiotic susceptibility patterns of microorganisms cultured from suture material
3. To compare suture contamination rates with techniques to reduce the suture contamination rate
Detailed Description
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Institutional standard surgical preparation will be performed in all patients with 5% povidone-iodine solution on the periocular skin and eyelid margins, followed by instillation of 1 drop of 5% povidone-iodine into the conjunctival cul-de-sac.
All operations will be performed using a sliding noose technique with a polyglactin 6-0 suture (Vicryl, Ethicon Inc). If a patient undergoes surgery on more than 1 muscle in the same eye, a 1-cm section of suture proximal to the knot will be collected from the nonadjustable suture as a control. The control suture will be placed in a tube with 2 mL of trypticase soy broth and agitated for 1 minute. At the end of surgery, patients in group 1 will receive a drop of povidone-iodine. A strip of neomycin sulfate, polymyxin B sulfate, and dexamethasone ophthalmic ointment will be then applied into the lower conjunctival fornix to patients in both groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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5% povidone iodine ophthalmic solution
patient received 1 drop of 5% povidone-iodine instilled over the adjustable suture noose in addition to routine antibiotic/steroid ointment to operated eye at surgery completion
5%povidone iodine ophthalmic solution
one drop of 5% povidone iodine instilled into the conjunctival fornix.
routine post-operative ophthalmic ointment
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
no povidone-iodine ophthalmic solution
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
routine post-operative ophthalmic ointment
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
Interventions
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5%povidone iodine ophthalmic solution
one drop of 5% povidone iodine instilled into the conjunctival fornix.
routine post-operative ophthalmic ointment
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Disorders affecting immune function.
* Patient who is unwilling to participate in the study
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Hilda Capo
Professor of Clinical
Principal Investigators
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Hilda Capo, MD
Role: PRINCIPAL_INVESTIGATOR
Bascom Palmer Eye Institute
Locations
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Bascom Palmer Eye Institute, University of Miami
Miami, Florida, United States
Countries
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References
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Eustis HS, Rhodes A. Suture contamination in strabismus surgery. J Pediatr Ophthalmol Strabismus. 2012 Jul-Aug;49(4):206-9. doi: 10.3928/01913913-20110920-01.
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.
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.
Apt L, Isenberg SJ, Yoshimori R, Chang A, Lam GC, Wachler B, Neumann D. The effect of povidone-iodine solution applied at the conclusion of ophthalmic surgery. Am J Ophthalmol. 1995 Jun;119(6):701-5. doi: 10.1016/s0002-9394(14)72773-4.
Rossetto JD, Suwannaraj S, Cavuoto KM, Spierer O, Miller D, McKeown CA, Capo H. Evaluation of Postoperative Povidone-Iodine in Adjustable Suture Strabismus Surgery to Reduce Suture Colonization: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1151-1155. doi: 10.1001/jamaophthalmol.2016.2926.
Other Identifiers
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20150111
Identifier Type: -
Identifier Source: org_study_id