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Antimicrobial Coated Device

Group 1: Microlyte will be cut into strips and placed on the surgical incision for Ventral Hernia

N/A
Waitlist Available
Led By Alfredo M Carbonell, DO
Research Sponsored by Prisma Health-Upstate
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial is to study if a silver-coated dissolvable sheet reduces infection rates in those having open ventral hernia repair surgery. FDA has cleared the device for use, 280 people will be included, & it will last 90 days.

Eligible Conditions
  • Ventral Hernia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of SSI following clean OVHR with and without Microlyte.
Secondary outcome measures
Rate of other wound complications, including superficial wound breakdown, seroma formation, and mesh infection, with/without Microlyte.
Rate of short-term readmissions with and without Microlyte

Trial Design

2Treatment groups
Active Control
Group I: Group 2: Nothing will be placed on the surgical incisionActive Control1 Intervention
Nothing will be placed on the surgical incision
Group II: Group 1: Microlyte will be cut into strips and placed on the surgical incisionActive Control1 Intervention
Microlyte will be cut into strips and placed on the surgical incision

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesOTHER
1,242 Previous Clinical Trials
1,004,255 Total Patients Enrolled
Kendall Healthcare Group, Ltd.Industry Sponsor
6 Previous Clinical Trials
1,364 Total Patients Enrolled
Prisma Health-UpstateLead Sponsor
82 Previous Clinical Trials
42,938 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Microlyte in Prevention of SSI After Open Ventral Hernia Repair
2021. "Microlyte in Prevention of SSI After Open Ventral Hernia Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05093894.
~0 spots leftby Apr 2025
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