Suture Contamination Rate in Adjustable Suture Strabismus Surgery

Study Overview
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Brief Summary
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To establish the culture positivity rate in adjustable suture strabismus surgery To identify bacterial species and antibiotic susceptibility patterns of microorganisms cultured from suture material To compare suture contamination rates with techniques to reduce the suture contamination rate

Detailed Description
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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.

Official Title
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Suture Contamination Rate in Adjustable Suture Strabismus Surgery

Conditions
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Suture Strabismus Surgery

Intervention / Treatment
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* Drug: 5%povidone iodine ophthalmic solution
* Drug: routine post-operative ophthalmic ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5% povidone iodine ophthalmic solution<br>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 | Drug: 5%povidone iodine ophthalmic solution<br>* one drop of 5% povidone iodine instilled into the conjunctival fornix.<br>* Other names: 5%Betadine ophthalmic drop;Drug: routine post-operative ophthalmic ointment<br>* patient received a routine antibiotic/steroid ointment to operated eye at surgery completion<br>|
| Active Comparator: no povidone-iodine ophthalmic solution<br>patient received a routine antibiotic/steroid ointment to operated eye at surgery completion | Drug: routine post-operative ophthalmic ointment<br>* patient received a routine antibiotic/steroid ointment to operated eye at surgery completion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suture Colonization Rate in Adjustable Suture Strabismus Surgery | 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 | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine | Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion | 48 hours | 
| Identification of Bacterial Species Cultured From Suture Material | 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. | 7 days plus 24 to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjustable strabismus surgery, suture contamination, 5%povidone iodine