A Prospective, Multicenter Randomized Study of Microlyte - AG Bioresorbable Matrix in the Prevention of Surgical Site Infection After Open Ventral Hernia Repair
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Prisma Health-Upstate
- Locations
- 3
- Primary Endpoint
- Rate of SSI following clean OVHR with and without Microlyte.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Group 1 (Device)
Group 2: Nothing will be placed on the surgical incision
Nothing will be placed on the surgical incision
Outcomes
Primary Outcomes
Rate of SSI following clean OVHR with and without Microlyte.
Time Frame: 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 Outcomes
- Rate of other wound complications, including superficial wound breakdown, seroma formation, and mesh infection, with/without Microlyte.(90 days)
- Rate of short-term readmissions with and without Microlyte(30-days)