Clinical Trials Directory

Trials / Unknown

UnknownNCT02795130

Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Ottawa Hospital Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2016-06-01
Primary completion
2017-06-01
First posted
2016-06-09
Last updated
2016-06-09

Source: ClinicalTrials.gov record NCT02795130. Inclusion in this directory is not an endorsement.

Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure (NCT02795130) · Clinical Trials Directory