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Microlyte in Prevention of SSI After Open Ventral Hernia Repair

NCT05093894 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-10-10

No results posted yet for this study

Summary

Participants who are scheduled to have open ventral hernia repair (OVHR) will be asked to take part in this study.

The purpose of this study is to find out if placing Microlyte (which is a dissolvable sheet coated in silver) on the surgical incision is better than placing nothing on the surgical incision when it comes to decreasing the chance of surgical site infections.

The study device has been cleared by the Food and Drug Administration (FDA) for use on surgical incisions.

A total of 280 participants will be included in the study.

Participation will last for about 90 days.

Conditions

  • Ventral Hernia

Interventions

DEVICE

Group 1

Microlyte will be cut into strips and placed on the subcutaneous space

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Kendall Healthcare Group, Ltd.

    collaborator INDUSTRY

  • Prisma Health-Upstate

    lead OTHER

Principal Investigators

  • Alfredo M Carbonell, DO · Prisma Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-14
Primary Completion
2022-10-06
Completion
2022-10-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05093894 on ClinicalTrials.gov