Clinical trial NCT05093894: Microlyte in Prevention of SSI After Open Ventral Hernia Repair
Official title: A Prospective, Multicenter Randomized Study of Microlyte - AG Bioresorbable Matrix in the Prevention of Surgical Site Infection After Open Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: Kendall Healthcare Group, Ltd.
First posted: 2021-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of SSI following clean OVHR with and without Microlyte.
timeFrame: 90 days
Secondary outcomes:
measure: Rate of other wound complications, including superficial wound breakdown, seroma formation, and mesh infection, with/without Microlyte.
timeFrame: 90 days
measure: Rate of short-term readmissions with and without Microlyte
timeFrame: 30-days
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Mission Hospital/HCA Healthcare
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center/Atrium Health
state: North Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Prisma Health
name: Alfredo M Carbonell, DO
role: PRINCIPAL_INVESTIGATOR
References: