Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

NCT02795130 | Unknown

• 1 other identifier: 20160382
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ophthalmologic Surgical Procedure

Outcome Measures

Primary Outcomes (1)

• Patient comfort

  One month post-operative patient comfort assessed using a 0-10 visual analogue scale

  1 month

Secondary Outcomes (4)

• Scleral/conjunctival inflammation

  1 month

• Visual Acuity

  1 month

• Intraocular Pressure

  1 month

• Complications

  1 month

Study Arms (2)

8-0 polyglactin 910

EXPERIMENTAL

Procedure: Sclerotomy closure

6-0 plain gut suture

EXPERIMENTAL

Procedure: Sclerotomy closure

Interventions

Sclerotomy closure PROCEDURE

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

6-0 plain gut suture; 8-0 polyglactin 910

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• History of previous vitrectomy in the study eye
• History of scleral buckling in the study eye
• Currently on peri-operative corticosteroid medicines (topical or systemic)
• Systemic chemotherapy within the preceding 6 months.
• History of any disorder or medication use associated with conjunctival, scleral, or episcleral inflammation and/or scarring
• History of narcotic abuse

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Central Study Contacts

Michael Dollin, MD, FRCSC

CONTACT

613-739-6997; mdollin@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 9, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Last Updated: June 9, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share