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

Study Overview

• Status: Completed
• Conditions: Suture Strabismus Surgery
• Intervention / Treatment: Drug: 5%povidone iodine ophthalmic solution; Drug: routine post-operative ophthalmic ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute, University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Hilda Capo, MD, Bascom Palmer Eye Institute

Publications and helpful links

General Publications

• Eustis HS, Rhodes A. Suture contamination in strabismus surgery. J Pediatr Ophthalmol Strabismus. 2012 Jul-Aug;49(4):206-9. doi: 10.3928/01913913-20110920-01.
• Olitsky SE, Vilardo M, Awner S, Reynolds JD. Needle sterility during strabismus surgery. J AAPOS. 1998 Jun;2(3):151-2. doi: 10.1016/s1091-8531(98)90006-4.
• Carothers TS, Coats DK, McCreery KM, Rossman SN, Wilson P, Wu TG, Paysse EA. Quantification of incidental needle and suture contamination during strabismus surgery. Binocul Vis Strabismus Q. 2003;18(2):75-9.
• Apt L, Isenberg SJ, Yoshimori R, Chang A, Lam GC, Wachler B, Neumann D. The effect of povidone-iodine solution applied at the conclusion of ophthalmic surgery. Am J Ophthalmol. 1995 Jun;119(6):701-5. doi: 10.1016/s0002-9394(14)72773-4.
• Rossetto JD, Suwannaraj S, Cavuoto KM, Spierer O, Miller D, McKeown CA, Capo H. Evaluation of Postoperative Povidone-Iodine in Adjustable Suture Strabismus Surgery to Reduce Suture Colonization: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1151-1155. doi: 10.1001/jamaophthalmol.2016.2926.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 22, 2015
• First Posted (Estimate): April 23, 2015

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Adjustable strabismus surgery; suture contamination; 5%povidone iodine
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Anti-Infective Agents, Local; Anti-Infective Agents; Pharmaceutical Solutions; Plasma Substitutes; Blood Substitutes; Ophthalmic Solutions; Povidone-Iodine; Povidone
• Other Study ID Numbers: 20150111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO