Microlyte in Prevention of SSI After Open Ventral Hernia Repair

NCT05093894 | Withdrawn FDA Device

• 1 other identifier: Pro00115720
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

ACTIVE COMPARATOR

Microlyte will be cut into strips and placed on the surgical incision

Device: Group 1

Group 2: Nothing will be placed on the surgical incision

NO INTERVENTION

Nothing will be placed on the surgical incision

Interventions

Group 1 DEVICE

Microlyte will be cut into strips and placed on the subcutaneous space

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Wake Forest University Health Sciences: collaborator
• Kendall Healthcare Group, Ltd.: collaborator

Study Sites (3)

Mission Hospital/HCA Healthcare

Asheville, North Carolina, 28801, United States

Location

Carolinas Medical Center/Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Alfredo M Carbonell, DO

  Prisma Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 26, 2021
• Study Start: December 14, 2021
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)