Suture Contamination Rate in Adjustable Suture Strabismus Surgery

University of Miami

Status: Completed

Conditions: Suture Strabismus Surgery

Treatments: Drug: routine post-operative ophthalmic ointment; Drug: 5%povidone iodine ophthalmic solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02424357

20150111

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups

5% povidone iodine ophthalmic solution

Experimental group

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

Treatment:

Drug: 5%povidone iodine ophthalmic solution

Drug: routine post-operative ophthalmic ointment

no povidone-iodine ophthalmic solution

Active Comparator group

Description:

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

Treatment:

Drug: routine post-operative ophthalmic ointment