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Suture Contamination Rate in Adjustable Suture Strabismus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02424357
Recruitment Status : Completed
First Posted : April 23, 2015
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hilda Capo, 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

Condition or disease Intervention/treatment Phase
Suture Strabismus Surgery Drug: 5%povidone iodine ophthalmic solution Drug: routine post-operative ophthalmic ointment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Primary Purpose: Prevention
Official Title: Suture Contamination Rate in Adjustable Suture Strabismus Surgery
Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Suture Colonization Rate in Adjustable Suture Strabismus Surgery [ Time Frame: 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 :
  1. Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine [ Time Frame: 48 hours ]
    Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion

  2. Identification of Bacterial Species Cultured From Suture Material [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424357


Locations
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United States, Florida
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Hilda Capo, MD Bascom Palmer Eye Institute
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hilda Capo, Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT02424357    
Other Study ID Numbers: 20150111
First Posted: April 23, 2015    Key Record Dates
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hilda Capo, University of Miami:
Adjustable strabismus surgery
suture contamination
5%povidone iodine
Additional relevant MeSH terms:
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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Povidone-Iodine
Povidone
Ophthalmic Solutions
Pharmaceutical Solutions
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents