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Clinical Trial Summary

1. To establish the culture positivity rate in adjustable suture strabismus surgery

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


Clinical Trial Description

Patients will be randomized into 1 of 2 groups: those who received 1 drop of 5% povidone-iodine instilled directly over the sliding noose at surgery completion (group 1) and those who did not receive povidone-iodine at the end of the surgery (group 2).

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02424357
Study type Interventional
Source University of Miami
Contact
Status Completed
Phase N/A
Start date July 2015
Completion date February 2016