Hernia, VentralCVHRNCT02041494
Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh
A study testing Ventralight and Strattice in people with Hernia, Ventral, run by Hobart Harris at 1 site in United States.
Trial summary
Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- Ventralight and Strattice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 5 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical evidence of a midline, ventral hernia, regardless of degree of wound contamination, with the exception of class IV wounds due to the presence/discovery of fecal peritonitis. Specifically, the repair will or will not involve a compromised surgical field in which gastrointestinal, biliary and/or genitourinary procedures will be performed. The surgical wound class may be classified as clean, or it may be classified as clean-contaminated, contaminated, or dirty-infected, due to the repair of an enterocutaneous fistula, takedown of an intestinal stoma and/or removal of infected mesh
- Age >21
- Negative pregnancy test
- No allergic, religious or ethical objections to either polypropylene or porcine prosthetics
- Signed, witnessed informed consent to take part in the study
Who cannot join
- Lactating women
- Patients who are unable to commit to the follow evaluations over 24 months
- Severe malnutrition (serum albumin <2.0 in the setting of a normal CRP)
- Use of an investigational agent within 1 month prior to study enrollment and/or planned during this study
- Presence of pre-existing parenchymal liver disease characterized by the presence of Child's Class C liver dysfunction (including all of the following: bilirubin ≥ 3.0 mg/dL; albumin ≤ 3.0 mg/dL; refractory ascites; encephalopathy or coma; and poor nutritional status)
- Immunocompromised patients, as evidenced by: administration of high doses of corticosteroids (i.e. doses ≥ 1.5 mg/kg/day of prednisone or equivalent) within 72 hours before study enrollment; status post solid organ transplant or bone marrow transplant and experiencing acute organ rejection or bone marrow failure or rejection; evidence of neutropenia (absolute neutrophil count ≤ 500 cells/mm3 (≤ 500 x 106 cells/L); chemotherapy or radiation therapy within 90 days before study enrollment; known AIDS; any disease sufficiently advanced to suppress resistance to infection (including, but not limited to leukemia, lymphoma or hypogammaglobulinemia); administration of immunoglobulin of G-CSF within 90 days before study enrollment
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- Ascites refractory to medical management
- Presence of an underlying disease/injury with life expectancy less than two years and/or severe underlying disease that would preclude study entry (e.g. known malignancy)
- Wound Classification IV due to the presence/discovery of fecal peritonitis. Other cases of wound class IV including presence of purulent inflammation, soft tissue/mesh infection, or visceral perforation resulting in a contained fistula (e.g. enterocutaneous fistula) are still considered eligible for enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94131
About this study
Official title: Study Comparing the Efficacy, Safety, and Cost of a Permanent, Synthetic Prosthetic Versus a Biologic Prosthetic in the One-stage Repair of Ventral Hernias in Clean and Contaminated Wounds.
Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited. The purpose of this study is to compare the effects, good and/or bad, of two types of prosthetic meshes: one that is made from pig skin (called a "biologic prosthetic"), and one that is made in a laboratory (called a "synthetic prosthetic"). This study will include some patients who have an infection in/near the hernia, and other patients who do not have an infection. We expect the synthetic mesh to be associated with a higher rate of early post-operative surgical site infection and fluid collections (seromas), while we expect the biologic mesh to be associated with a higher rate of recurrence.
Read the detailed description
This is a prospective, single-blind, randomized study comparing the clinical efficacy and overall costs of two prosthetic meshes in the repair of complex ventral hernias. The two prosthetic meshes to be studied are Ventralight (Bard, Murray Hill, NJ), a synthetic mesh chiefly made of polypropylene and Strattice (LifeCell, Branchburg, NJ), a biologic mesh derived from porcine dermis. The study population will consist of patients who are in need of a repair of a complex ventral hernia. Patients will be enrolled in the study for 24 months following their operation or until they experience a recurrence of their hernia, whichever occurs first. The primary outcome variable is recurrence and the secondary outcome variables are post-operative surgical site infections and overall costs.
There is no universally agreed upon definition of what constitutes a "complex" ventral hernia. For our purposes, a "complex" ventral hernia is one that involves a compromised surgical field, in which gastrointestinal, biliary, or genitourinary procedures are performed, one in which the wound class is considered clean-contaminated, contaminated, or dirty due to other causes, such as infected meshes and enterocutaneous fistulas, or surgical procedures conducted in patients with large ventral hernia defects (>10 cm in any single dimension).
- Conditions
- Hernia, Ventral
- Being tested
- Ventralight, Strattice
- Keywords
- Hernia, Ventral, Incisional, Abdominal, Herniorrhaphy, Recurrence, Infection, Mesh, Biologic, Synthetic
- Medical subject headings
- Hernia, Ventral, Hernia, Surgical Wound, Recurrence, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentralightDevice
Also called Ventralight ST Mesh, K101851
StratticeDevice
Also called LTM Surgical Mesh, K070560
| Study group | Role | What they receive |
|---|---|---|
| Synthetic | Active comparator | Patients in this arm will have their ventral hernia repaired utilizing Ventralight, a synthetic prosthetic mesh made of polypropylene. Receives: Device: Ventralight |
| Biologic | Active comparator | Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. Receives: Device: Strattice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair.
Number of patients who had a recurrence of hernia, at anytime, up to two years following repair as determined by physical examination, ultrasound or CT scan.
Measured: up to 24 months after surgery
Secondary outcomes (1)
Number of Patients Who Experienced Surgical Site Infections.
Number of patients who experienced surgical site infections as determined by physical examination.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startMar 2014
- Primary completion5 Oct 2019
- Study completion5 Oct 2019
Why it stopped: Rising costs have made continuing the study untenable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, VentralStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hobart Harris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hobart Harris, University of California, San Francisco
- Investigators
- Hobart W. Harris, M.D., M.P.H., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041494
- Sponsor's protocol ID
- UCSF-NIDDK-1R21DK093006-01A1
- Other IDs
- 1R21DK093006-01A1
- Acronym
- CVHR
- Status last verified
- Feb 2021
- First submitted
- 18 Jan 2014
- Last updated
- 14 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Harris HW, Primus F, Young C, Carter JT, Lin M, Mukhtar RA, Yeh B, Allen IE, Freise C, Kim E, Sbitany H, Young DM, Hansen S. Preventing Recurrence in Clean and Contaminated Hernias Using Biologic Versus Synthetic Mesh in Ventral Hernia Repair: The PRICE Randomized Clinical Trial. Ann Surg. 2021 Apr 1;273(4):648-655. doi: 10.1097/SLA.0000000000004336.
PubMed 33443907
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing the Efficacy, Safety, and Cost of a Permanent, Synthetic Prosthetic Versus a Biologic Prosthetic in the One-stage Repair of Ventral Hernias in Clean and Contaminated Wounds.
- ClinicalTrials.gov ID
- NCT02041494
- Acronym / sponsor ID
- CVHR / UCSF-NIDDK-1R21DK093006-01A1
- Conditions
- Hernia, Ventral
- Keywords
- Hernia, Ventral, Incisional, Abdominal, Herniorrhaphy, Recurrence, Infection, Mesh
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Rising costs have made continuing the study untenable
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Hobart HarrisUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2014 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 5 Oct 2019 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Posted 14 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited. The purpose of this study is to compare the effects, good and/or bad, of two types of prosthetic meshes: one that is made from pig skin (called a "biologic prosthetic"), and one that is made in a laboratory (called a "synthetic prosthetic"). This study will include some patients who have an infection in/near the hernia, and other patients who do not have an infection. We expect the synthetic mesh to be associated with a higher rate of early post-operative surgical site infection and fluid collections (seromas), while we expect the biologic mesh to be associated with a higher rate of recurrence.
Detailed description
This is a prospective, single-blind, randomized study comparing the clinical efficacy and overall costs of two prosthetic meshes in the repair of complex ventral hernias. The two prosthetic meshes to be studied are Ventralight (Bard, Murray Hill, NJ), a synthetic mesh chiefly made of polypropylene and Strattice (LifeCell, Branchburg, NJ), a biologic mesh derived from porcine dermis. The study population will consist of patients who are in need of a repair of a complex ventral hernia. Patients will be enrolled in the study for 24 months following their operation or until they experience a recurrence of their hernia, whichever occurs first. The primary outcome variable is recurrence and the secondary outcome variables are post-operative surgical site infections and overall costs.
There is no universally agreed upon definition of what constitutes a "complex" ventral hernia. For our purposes, a "complex" ventral hernia is one that involves a compromised surgical field, in which gastrointestinal, biliary, or genitourinary procedures are performed, one in which the wound class is considered clean-contaminated, contaminated, or dirty due to other causes, such as infected meshes and enterocutaneous fistulas, or surgical procedures conducted in patients with large ventral hernia defects (>10 cm in any single dimension).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synthetic | Active comparator | Device: VentralightPatients in this arm will have their ventral hernia repaired utilizing Ventralight, a synthetic prosthetic mesh made of polypropylene. |
| Biologic | Active comparator | Device: StratticePatients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical evidence of a midline, ventral hernia, regardless of degree of wound contamination, with the exception of class IV wounds due to the presence/discovery of fecal peritonitis. Specifically, the repair will or will not involve a compromised surgical field in which gastrointestinal, biliary and/or genitourinary procedures will be performed. The surgical wound class may be classified as clean, or it may be classified as clean-contaminated, contaminated, or dirty-infected, due to the repair of an enterocutaneous fistula, takedown of an intestinal stoma and/or removal of infected mesh
- Age >21
- Negative pregnancy test
- No allergic, religious or ethical objections to either polypropylene or porcine prosthetics
- Signed, witnessed informed consent to take part in the study
Key exclusion criteria (9 listed)
- Lactating women
- Patients who are unable to commit to the follow evaluations over 24 months
- Severe malnutrition (serum albumin <2.0 in the setting of a normal CRP)
- Use of an investigational agent within 1 month prior to study enrollment and/or planned during this study
- Presence of pre-existing parenchymal liver disease characterized by the presence of Child's Class C liver dysfunction (including all of the following: bilirubin ≥ 3.0 mg/dL; albumin ≤ 3.0 mg/dL; refractory ascites; encephalopathy or coma; and poor nutritional status)
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 |
|---|---|---|
| VentralightAlso: Ventralight ST Mesh, K101851 | Device | Synthetic |
| StratticeAlso: LTM Surgical Mesh, K070560 | Device | Biologic |
Primary outcome
Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair.
Time frame: up to 24 months after surgery
Number of patients who had a recurrence of hernia, at anytime, up to two years following repair as determined by physical examination, ultrasound or CT scan.
1 secondary outcome
Number of Patients Who Experienced Surgical Site Infections.
Time frame: 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33443907Harris HW, Primus F, Young C, Carter JT, Lin M, Mukhtar RA, Yeh B, Allen IE, Freise C, Kim E, Sbitany H, Young DM, Hansen S. Preventing Recurrence in Clean and Contaminated Hernias Using Biologic Versus Synthetic Mesh in Ventral Hernia Repair: The PRICE Randomized Clinical Trial. Ann Surg. 2021 Apr 1;273(4):648-655. doi: 10.1097/SLA.0000000000004336.
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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.
Hobart W. Harris, M.D., M.P.H. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventralight and Strattice in people with Hernia, Ventral, run by Hobart Harris 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair. (time frame: up to 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02041494, which also lists 1 linked publication.
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 14 Apr 2021.