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Suture Contamination Rate in Adjustable Suture Strabismus Surgery

Primary Purpose

Suture Strabismus Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5%povidone iodine ophthalmic solution
routine post-operative ophthalmic ointment
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suture Strabismus Surgery focused on measuring Adjustable strabismus surgery, suture contamination, 5%povidone iodine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bascom Palmer Eye Institute, University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5% povidone iodine ophthalmic solution

no povidone-iodine ophthalmic solution

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
April 20, 2015
Last Updated
November 29, 2017
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02424357
Brief Title
Suture Contamination Rate in Adjustable Suture Strabismus Surgery
Official Title
Suture Contamination Rate in Adjustable Suture Strabismus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suture Strabismus Surgery
Keywords
Adjustable strabismus surgery, suture contamination, 5%povidone iodine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5% povidone iodine ophthalmic solution
Arm Type
Experimental
Arm 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
Arm Title
no povidone-iodine ophthalmic solution
Arm Type
Active Comparator
Arm Description
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
Intervention Type
Drug
Intervention Name(s)
5%povidone iodine ophthalmic solution
Other Intervention Name(s)
5%Betadine ophthalmic drop
Intervention Description
one drop of 5% povidone iodine instilled into the conjunctival fornix.
Intervention Type
Drug
Intervention Name(s)
routine post-operative ophthalmic ointment
Intervention Description
patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
Primary Outcome Measure Information:
Title
Suture Colonization Rate in Adjustable Suture Strabismus Surgery
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine
Description
Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion
Time Frame
48 hours
Title
Identification of Bacterial Species Cultured From Suture Material
Description
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.
Time Frame
7 days plus 24 to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilda Capo, MD
Organizational Affiliation
Bascom Palmer Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22909077
Citation
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.
Results Reference
background
PubMed Identifier
10532751
Citation
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.
Results Reference
background
PubMed Identifier
12765540
Citation
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.
Results Reference
background
PubMed Identifier
7540363
Citation
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.
Results Reference
background
PubMed Identifier
27561000
Citation
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.
Results Reference
derived

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Suture Contamination Rate in Adjustable Suture Strabismus Surgery

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