Microlyte in Prevention of SSI After Open Ventral Hernia Repair

A Prospective, Multicenter Randomized Study of Microlyte - AG Bioresorbable Matrix in the Prevention of Surgical Site Infection After Open Ventral Hernia Repair

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.

Study Overview

• Status: Withdrawn
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Group 1

Detailed Description

The aim of our study is to assess the impact of Microlyte-AG® (Imbed Biosciences, Fitchburg, WI), a silver-coated bioabsorbable matrix, on surgical site infection (SSI) on patients undergoing clean open ventral hernia repair (OVHR) at Carolinas Medical Center/Atrium Health (Charlotte, NC), Prisma Health-Upstate (Greenville, SC), and Mission Health/HCA Healthcare (Asheville, NC).

Those who agree to participate in the study will undergo the following:

Information will be collected, including demographics, past medical and surgical history, and hospital outcomes.

On the day of surgery, participants will be "randomized" into one of the study groups listed below.

• Group 1: The study device will be cut into strips and placed in the surgical incision
• Group 2: Nothing will be placed in the surgical incision

For both groups, the surgical incision will then be closed with absorbable sutures, which is the usual treatment.

Participants will be seen by the study doctor 30 and 90 days after surgery for a checkup. At the 30-day visit, participants will have a physical examination, and the study doctor will check to see if any complications have happened since the last visit. The 90-day follow-up visit can be done in person or over the telephone and will be done to check and see if there have been any problems with the healing of the surgical incision.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital/HCA Healthcare
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center/Atrium Health
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women over 18 years of age
• Patients undergoing open hernia repair with retromuscular or preperitoneal placement of polypropylene mesh in clean (Class I) operative fields, and who are candidates for complete skin closure
• Capable and willing to attend the scheduled postoperative visits
• Signed ICF for study enrollment

Exclusion Criteria:

• Prisoners
• Minimally invasive repairs (laparoscopy, robotics)
• CDC Wound Class II-IV
• Irrigation of the wound or peritoneal cavity with antibiotic or antimicrobial fluid
• Inability to completely close the midline fascia
• Mesh placed as a bridge, onlay, or intraperitoneal position to the fascia
• Skin left open or packed at the time of the index operation
• Use of wound wicks at the time of the index operation
• Use of an investigational product within the preceding 60 days
• Allergy to silver

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Microlyte will be cut into strips and placed on the surgical incision; Microlyte will be cut into strips and placed on the surgical incision	Device: Group 1; Microlyte will be cut into strips and placed on the subcutaneous space
No Intervention: Group 2: Nothing will be placed on the surgical incision; Nothing will be placed on the surgical incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of SSI following clean OVHR with and without Microlyte.	SSI, which is the primary outcome that will be measured for the study will be as an infection of the skin or subcutaneous tissues as clinically determined by the physician caring for the patient	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of other wound complications, including superficial wound breakdown, seroma formation, and mesh infection, with/without Microlyte.	Other wound complications will be defined based on a combination of clinical assessment and review of postoperative notes and imaging	90 days
Rate of short-term readmissions with and without Microlyte	Short-term readmissions	30-days

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: Wake Forest University Health Sciences; Kendall Healthcare Group, Ltd.
• Investigators: Principal Investigator: Alfredo M Carbonell, DO, Prisma Health

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Actual): October 6, 2022
• Study Completion (Actual): October 6, 2022

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: Pro00115720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No