Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT05093894
Status:
WITHDRAWN
Last Update Posted:
2022-10-10
First Post:
2021-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microlyte in Prevention of SSI After Open Ventral Hernia Repair
Sponsor:
Prisma Health-Upstate
Organization:
Study Overview
Official Title:
A Prospective, Multicenter Randomized Study of Microlyte - AG Bioresorbable Matrix in the Prevention of Surgical Site Infection After Open Ventral Hernia Repair
Status:
WITHDRAWN
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI decided not to continue study due to no funding.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: