Microlyte in Prevention of SSI After Open Ventral Hernia Repair

Not Applicable

Withdrawn

• Conditions: Ventral Hernia
• Interventions: Device: Group 1

• Registration Number: NCT05093894
• Lead Sponsor: Prisma Health-Upstate

Brief 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.

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 Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-26
• Study Start: 2021-12-14
• Status Verified: 2022-10
• Primary Completion: 2022-10-06
• Study Completion: 2022-10-06
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Microlyte will be cut into strips and placed on the surgical incision	Group 1	Microlyte will be cut into strips and placed on the surgical incision

Primary Outcome Measures

Name	Time	Method
Rate of SSI following clean OVHR with and without Microlyte.	90 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Carolinas Medical Center/Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Prisma Health; 🇺🇸 Greenville, South Carolina, United States

Mission Hospital/HCA Healthcare; 🇺🇸 Asheville, North Carolina, United States