Ventral HerniaNCT05093894
Microlyte in Prevention of SSI After Open Ventral Hernia Repair
A study testing Group 1 in people with Ventral Hernia, run by Prisma Health-Upstate at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Group 1
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Dec 2021to 6 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mission Hospital/HCA Healthcare
Asheville, North Carolina, 28801
Carolinas Medical Center/Atrium Health
Charlotte, North Carolina, 28204
Prisma Health
Greenville, South Carolina, 29605
About this study
Official title: A Prospective, Multicenter Randomized Study of Microlyte - AG Bioresorbable Matrix in the Prevention of Surgical Site Infection After Open Ventral Hernia Repair
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.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- Group 1
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Device
Microlyte will be cut into strips and placed on the subcutaneous space
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Group 1 |
| Group 2: Nothing will be placed on the surgical incision | No intervention | Nothing will be placed on the surgical incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (2)
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
Measured: 90 days
Rate of short-term readmissions with and without Microlyte
Short-term readmissions
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start14 Dec 2021
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Why it stopped: PI decided not to continue study due to no funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Kendall Healthcare Group, Ltd.
- Responsible party
- Sponsor
- Investigators
- Alfredo M Carbonell, DO, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093894
- Sponsor's protocol ID
- Pro00115720
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Randomized Study of Microlyte - AG Bioresorbable Matrix in the Prevention of Surgical Site Infection After Open Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT05093894
- Acronym / sponsor ID
- Pro00115720
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided not to continue study due to no funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Kendall Healthcare Group, Ltd.
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Microlyte will be cut into strips and placed on the surgical incision | Active comparator | Device: Group 1Microlyte will be cut into strips and placed on the surgical incision |
| Group 2: Nothing will be placed on the surgical incision | No intervention | –Nothing will be placed on the surgical incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1Microlyte will be cut into strips and placed on the subcutaneous space | Device | Group 1: Microlyte will be cut into strips and placed on the surgical incision |
Primary outcome
Rate of SSI following clean OVHR with and without Microlyte.
Time frame: 90 days
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
2 secondary outcomes
Rate of other wound complications, including superficial wound breakdown, seroma formation, and mesh infection, with/without Microlyte.
Time frame: 90 days
Rate of short-term readmissions with and without Microlyte
Time frame: 30-days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo M Carbonell, DO principal investigator
Prisma Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 in people with Ventral Hernia, run by Prisma Health-Upstate at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of SSI following clean OVHR with and without Microlyte. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.