Suture Contamination Rate in Adjustable Suture Strabismus Surgery

Suture Contamination Rate in Adjustable Suture Strabismus Surgery

Sponsors

Lead Sponsor: University of Miami

Source 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.

Overall Status Completed
Start Date July 2015
Completion Date February 2016
Primary Completion Date January 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Suture Colonization Rate in Adjustable Suture Strabismus Surgery 48 hours
Secondary Outcome
Measure Time Frame
Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine 48 hours
Identification of Bacterial Species Cultured From Suture Material 7 days plus 24 to 48 hours
Enrollment 65
Condition
Intervention

Intervention Type: Drug

Intervention Name: 5%povidone iodine ophthalmic solution

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

Arm Group Label: 5% povidone iodine ophthalmic solution

Other Name: 5%Betadine ophthalmic drop

Intervention Type: Drug

Intervention Name: routine post-operative ophthalmic ointment

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

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Hilda Capo, MD Principal Investigator Bascom Palmer Eye Institute
Location
Facility: Bascom Palmer Eye Institute, University of Miami
Location Countries

United States

Verification Date

November 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Miami

Investigator Full Name: Hilda Capo

Investigator Title: Professor of Clinical

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 5% povidone iodine ophthalmic solution

Type: Experimental

Description: 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

Label: no povidone-iodine ophthalmic solution

Type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Masking Description: The surgeon will be unaware of the randomization until the end of the surgery. All microbiology personnel and patients will be unaware of the interventional group

Source: ClinicalTrials.gov