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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05093894
Other study ID # Pro00115720
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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