Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

• ClinicalTrials.gov Identifier: NCT02795130
• Recruitment Status: Unknown
• First Posted: June 9, 2016
• Last Update Posted: June 9, 2016
• Sponsor: Ottawa Hospital Research Institute
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Tracking Information

• First Submitted Date: June 6, 2016
• First Posted Date: June 9, 2016
• Last Update Posted Date: June 9, 2016
• Study Start Date: June 2016
• Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ophthalmologic Surgical Procedure

Intervention

Procedure: Sclerotomy closure

Comparison between two suture materials: 1) 8-0 polyglactin 910, 2) 6-0 plain gut

Study Arms

• Experimental: 8-0 polyglactin 910
  Intervention: Procedure: Sclerotomy closure
• Experimental: 6-0 plain gut suture
  Intervention: Procedure: Sclerotomy closure

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 6, 2016): 40
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02795130
• Other Study ID Numbers: 20160382
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Responsible Party: Ottawa Hospital Research Institute
• Study Sponsor: Ottawa Hospital Research Institute
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ottawa Hospital Research Institute
• Verification Date: June 2016