Suture Contamination Rate in Adjustable Suture Strabismus Surgery

Not Applicable

Completed

• Conditions: Suture Strabismus Surgery
• Interventions: Drug: 5%povidone iodine ophthalmic solution; Drug: routine post-operative ophthalmic ointment

• Registration Number: NCT02424357
• Lead Sponsor: University of Miami

Brief 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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-23
• Study Start: 2015-07
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Results First Submitted: 2017-07-14
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-29
• Last Update Submitted: 2017-11-29
• Results First Posted: 2017-11-30
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5% povidone iodine ophthalmic solution	routine post-operative ophthalmic ointment	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	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
no povidone-iodine ophthalmic solution	routine post-operative ophthalmic ointment	patient received a routine antibiotic/steroid ointment to operated eye at surgery completion

Primary Outcome Measures

Name	Time	Method
Suture Colonization Rate in Adjustable Suture Strabismus Surgery	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 Outcome Measures

Name	Time	Method
Identification of Bacterial Species Cultured From Suture Material	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.
Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine	48 hours	Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion

Trial Locations

Locations (1)

Bascom Palmer Eye Institute, University of Miami; 🇺🇸 Miami, Florida, United States