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OpenTrials
Completed

NCT Number: NCT02424357

Suture Contamination Rate in Adjustable Suture Strabismus Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bascom Palmer Eye Institute, University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All strabismus patients age ≥ 18 years scheduled for strabismus surgery with adjustable sutures at the Bascom Palmer Eye Institute will be invited to participate.

Exclusion criteria

  • Patient who has a history of allergy to povidone-iodine.
  • Disorders affecting immune function.
  • Patient who is unwilling to participate in the study

Treatment and study plan

5%povidone iodine ophthalmic solution

Drug

one drop of 5% povidone iodine instilled into the conjunctival fornix.

Other names: 5%Betadine ophthalmic drop

routine post-operative ophthalmic ointment

Drug

patient received a routine antibiotic/steroid ointment to operated eye at surgery completion

Primary outcomes

  1. Suture Colonization Rate in Adjustable Suture Strabismus Surgery

    Time frame: 48 hours

    1 cm section of the suture proximal to the knot will be harvested and placed in a tube with 2 ml of trypticase soy broth (TSB).The TSB tubes will be monitored for growth of bacteria at 48 hours

Secondary outcomes

  1. Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine

    Time frame: 48 hours

    Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion

  2. Identification of Bacterial Species Cultured From Suture Material

    Time frame: 7 days plus 24 to 48 hours

    The collected sutures will be monitored for bacterial growth for up to 7 days. When bacterial growth is observed, 1 mL of the solution will be inoculated on chocolate, MacConkey, and anaerobic blood agars and incubated for an additional 24 to 48 hours to identify organisms and quantify growth. In vitro susceptibility patterns will be determined.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2015
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.