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Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

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ClinicalTrials.gov Identifier: NCT02795130
Recruitment Status : Unknown
Verified June 2016 by Ottawa Hospital Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE June 6, 2016
First Posted Date  ICMJE June 9, 2016
Last Update Posted Date June 9, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
Patient comfort [ Time Frame: 1 month ]
One month post-operative patient comfort assessed using a 0-10 visual analogue scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Scleral/conjunctival inflammation [ Time Frame: 1 month ]
    Rated on a 0 to 4+ scale
  • Visual Acuity [ Time Frame: 1 month ]
  • Intraocular Pressure [ Time Frame: 1 month ]
  • Complications [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure
Official Title  ICMJE Not Provided
Brief Summary Small-incision vitrectomy techniques have become increasingly popular, with a number of advantages over the older 20-gauge instrumentation. The beveled wounds created by the 23- and 25-gauge trocar systems theoretically do not require sutured closure. However, a certain fraction of cases, 1% for 25-gauge systems, and 4-38% for 23-gauge systems, do require suture placement. Poor wound closure puts the patient at increased risk of post-operative hypotony and is associated with increased risk of endophthalmitis. Currently, surgeons are divided as to which suture is the best for sclerotomy closure. The current standard of care is 8-0 polyglactin 910 (Vicryl, Ethicon, Cincinnati, OH). This suture is soft and easy to work with; however, it triggers a robust inflammatory response. The alternative is 6-0 plain gut suture, which is more difficult to manipulate and thicker, but causes less tissue inflammation1. The purpose of this study is to prospectively evaluate these two options for sclerotomy closure. The results of this study will enable us to minimize patients' post-operative discomfort while maximizing safety outcomes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ophthalmologic Surgical Procedure
Intervention  ICMJE Procedure: Sclerotomy closure
Comparison between two suture materials: 1) 8-0 polyglactin 910, 2) 6-0 plain gut
Study Arms  ICMJE
  • Experimental: 8-0 polyglactin 910
    Intervention: Procedure: Sclerotomy closure
  • Experimental: 6-0 plain gut suture
    Intervention: Procedure: Sclerotomy closure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient of Dr. Michael Dollin
  • Age 18 years and older
  • Scheduled to undergo 23-gauge pars plana vitrectomy for any indication that would most likely require sutures (E.g. retinal detachment)

Exclusion Criteria:

  1. History of previous vitrectomy in the study eye
  2. History of scleral buckling in the study eye
  3. Currently on peri-operative corticosteroid medicines (topical or systemic)
  4. Systemic chemotherapy within the preceding 6 months.
  5. History of any disorder or medication use associated with conjunctival, scleral, or episcleral inflammation and/or scarring
  6. History of narcotic abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02795130
Other Study ID Numbers  ICMJE 20160382
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ottawa Hospital Research Institute
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP