Microlyte in Prevention of SSI After Open Ventral Hernia Repair

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05093894
• Other study ID #: Pro00115720
• Status: Withdrawn
• Phase: N/A
• Start date: December 14, 2021
• Est. completion date: October 6, 2022

Study information

• Verified date: October 2022
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 6, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• Group 1
Microlyte will be cut into strips and placed on the subcutaneous space

Locations

Country	Name	City	State
United States	Mission Hospital/HCA Healthcare	Asheville	North Carolina
United States	Carolinas Medical Center/Atrium Health	Charlotte	North Carolina
United States	Prisma Health	Greenville	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Kendall Healthcare Group, Ltd., Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of short-term readmissions with and without Microlyte	Short-term readmissions	30-days