Ventral HerniaNCT04580524
Phasix Mesh Use in Complex Open Ventral Hernias Study
A study testing Repair of ventral hernia using biologic mesh and Repair of ventral hernia using suture repair or synthetic mesh in people with Ventral Hernia, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. 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?
- Repair of ventral hernia using biologic mesh and Repair of ventral hernia using suture repair or synthetic mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2021to Apr 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
- Adult patients (18 years or older) with a complex ventral hernia scheduled for repair
Who cannot join
- Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement)
- Unlikely to follow-up (live out of state, unable to be reached by phone or email)
- Non-English and non-Spanish speakers
- Pregnant or breast-feeding patients
- Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
Memorial Hermann Hospital-Texas Medical Center
Houston, Texas, 77030
About this study
Official title: Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial
The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).
- Conditions
- Ventral Hernia
- Being tested
- Repair of ventral hernia using biologic mesh, Repair of ventral hernia using suture repair or synthetic 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.
Repair of ventral hernia using biologic meshProcedure or surgery
Ventral hernia will be repaired using biologic mesh
Repair of ventral hernia using suture repair or synthetic meshProcedure or surgery
Ventral hernia will be repaired using the current treatment methods
| Study group | Role | What they receive |
|---|---|---|
| Phasix Mesh | Active comparator | Phasix mesh will be used in the repair of the hernia Receives: Procedure: Repair of ventral hernia using biologic mesh |
| Current Care | Active comparator | The hernia will be repaired with either synthetic mesh or suture repair, as determined by the operating surgeon. Receives: Procedure: Repair of ventral hernia using suture repair or synthetic mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complication free
A composite of hernia recurrence, reoperation, chronic wound complication, or death
Measured: 2 years post-operative
Secondary outcomes (7)
Surgical site occurrences
Surgical site infection, seroma, hematoma, and skin dehiscence
Measured: 90 days post-operative
Clavien-Dindo complication grade
Clavien-Dindo complication grade
Measured: 90 days post-operative
Hospital duration
Days in hospital composed of post-operative length of stay and readmissions
Measured: 90 days post-operative
Emergency room visits
Number of times ER was visited
Measured: 90 days post-operative
Cost Analysis
Analysis of costs as performed from the healthcare perspective
Measured: 2 years
Post-operative abdominal pain
Measured by the visual analogue scale (VAS)
Measured: Day of consent and post-operatively at 1 month, 1 year and 2 years
Patient centered outcomes
Abdominal wall health status (AW-HS) measured through the modified activities assessment scale (mAAS)
Measured: Day of consent and post-operatively at 1 month, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study startApr 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: Not able to secure 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 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 Holihan, MD, Principal investigator, UTHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580524
- Sponsor's protocol ID
- HSC-MS-20-0655
- Status last verified
- Jun 2023
- First submitted
- 2 Oct 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04580524
- Acronym / sponsor ID
- HSC-MS-20-0655
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to secure funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 8 Oct 2020 (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.
The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phasix Mesh | Active comparator | Procedure: Repair of ventral hernia using biologic meshPhasix mesh will be used in the repair of the hernia |
| Current Care | Active comparator | Procedure: Repair of ventral hernia using suture repair or synthetic meshThe hernia will be repaired with either synthetic mesh or suture repair, as determined by the operating surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18 years or older) with a complex ventral hernia scheduled for repair
Key exclusion criteria (5 listed)
- Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement)
- Unlikely to follow-up (live out of state, unable to be reached by phone or email)
- Non-English and non-Spanish speakers
- Pregnant or breast-feeding patients
- Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate
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 |
|---|---|---|
| Repair of ventral hernia using biologic meshVentral hernia will be repaired using biologic mesh | Procedure or surgery | Phasix Mesh |
| Repair of ventral hernia using suture repair or synthetic meshVentral hernia will be repaired using the current treatment methods | Procedure or surgery | Current Care |
Primary outcome
Major complication free
Time frame: 2 years post-operative
A composite of hernia recurrence, reoperation, chronic wound complication, or death
7 secondary outcomes
Surgical site occurrences
Time frame: 90 days post-operative
Clavien-Dindo complication grade
Time frame: 90 days post-operative
Hospital duration
Time frame: 90 days post-operative
Emergency room visits
Time frame: 90 days post-operative
Cost Analysis
Time frame: 2 years
Post-operative abdominal pain
Time frame: Day of consent and post-operatively at 1 month, 1 year and 2 years
Patient centered outcomes
Time frame: Day of consent and post-operatively at 1 month, 1 year and 2 years
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 22 Jun 2023.
- 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.
Julie Holihan, MD principal investigator
UTHealth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair of ventral hernia using biologic mesh and Repair of ventral hernia using suture repair or synthetic mesh in people with Ventral Hernia, run by The University of Texas Health Science Center, Houston at 2 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 1 inclusion and 5 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 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 2 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?
Major complication free (time frame: 2 years post-operative). 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.