Microlyte in Prevention of SSI After Open Ventral Hernia Repair

Prisma Health-Upstate

Status

Withdrawn

Conditions

Ventral Hernia

Treatments

Device: Group 1

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05093894

Pro00115720

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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