Ventral HerniaNCT03091790
Mesh Type in Ventral Hernia Repair
A study testing Synthetic Mesh and Biologic Mesh in people with Ventral Hernia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. 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?
- Synthetic Mesh and Biologic Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2017to 31 Jul 2021
- 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
- Patient scheduled for open ventral hernia repair at LBJ General Hospital
Who cannot join
- Active infection
- Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis)
- Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown)
- Patient unlikely to follow-up (i.e. no phone)
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health at Lyndon B. Johnson General Hospital
Houston, Texas, 77026
About this study
Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.
- Conditions
- Ventral Hernia
- Being tested
- Synthetic Mesh, Biologic Mesh
- Keywords
- ventral hernia, mesh
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic MeshDevice
Synthetic mesh used during open ventral hernia repair
Biologic MeshDevice
Biologic mesh used during open ventral hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Synthetic Mesh | Active comparator | Synthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair Receives: Device: Synthetic Mesh |
| Biologic Mesh | Active comparator | Biologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair Receives: Device: Biologic Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication free at 1 year post-operative
Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
Measured: 1 year after surgery
Secondary outcomes (4)
Complication free at 3 years post-operative
Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
Measured: 3 years after surgery
Dindo-clavien complications
Grade I to V
Measured: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Patient centered outcomes
includes patient satisfaction, cosmetic satisfaction, modified assessment scale
Measured: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Cost
charges for all patient visits, admissions, and procedures
Measured: 1 year and 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start27 Mar 2017
- Primary completion26 Jul 2020
- Study completion31 Jul 2021
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Holihan, The University of Texas Health Science Center, Houston
- Investigators
- Julie L Holihan, M.D., Principal investigator, UT Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091790
- Sponsor's protocol ID
- HSC-MS-16-0936
- Status last verified
- Jun 2023
- First submitted
- 21 Mar 2017
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Type in Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT03091790
- Acronym / sponsor ID
- HSC-MS-16-0936
- Conditions
- Ventral Hernia
- Keywords
- ventral hernia, mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 26 Jul 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 27 Mar 2017 (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.
Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synthetic Mesh | Active comparator | Device: Synthetic MeshSynthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair |
| Biologic Mesh | Active comparator | Device: Biologic MeshBiologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient scheduled for open ventral hernia repair at LBJ General Hospital
Key exclusion criteria (4 listed)
- Active infection
- Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis)
- Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown)
- Patient unlikely to follow-up (i.e. no phone)
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 |
|---|---|---|
| Synthetic MeshSynthetic mesh used during open ventral hernia repair | Device | Synthetic Mesh |
| Biologic MeshBiologic mesh used during open ventral hernia repair | Device | Biologic Mesh |
Primary outcome
Complication free at 1 year post-operative
Time frame: 1 year after surgery
Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
4 secondary outcomes
Complication free at 3 years post-operative
Time frame: 3 years after surgery
Dindo-clavien complications
Time frame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Patient centered outcomes
Time frame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Cost
Time frame: 1 year and 3 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Ventral Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Active, not recruitingObservational study
ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery
Ventral Hernia Repair
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.
Julie L Holihan, M.D. principal investigator
UT Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synthetic Mesh and Biologic Mesh in people with Ventral Hernia, run by The University of Texas Health Science Center, Houston at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complication free at 1 year post-operative (time frame: 1 year after surgery). 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 22 Jun 2023.