Ventral HerniaNCT02451176
Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias
A study testing Davol Bard Soft Mesh synthetic and LifeCell Strattice Reconstructive Tissue Biologic in people with Ventral Hernia, run by Michael Rosen at 4 sites in United States.
Trial summary
This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of clean-contaminated (Class 2) or contaminated (Class 3) surgical procedures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Davol Bard Soft Mesh synthetic and LifeCell Strattice Reconstructive Tissue Biologic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2015to 1 Apr 2021
- 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
- The subject is > 21 years of age (including women of childbearing age)
- Scheduled to undergo a planned open single stage reconstruction of a contaminated (CDC wound class2 or 3) abdominal wall defect
- Ability to undergo general anesthesia
- Is willing and able to give informed consent
- Is this a clean-contaminated (Class 2) or contaminated (Class 3) case per CDC Guidelines?
- Has an estimated parastomal hernia or midline defect size of >9 cm 2 contaminated (CDC wound class 2 or 3) abdominal wall defect by physical /or radiological exam.
- Can achieve midline fascial closure?
- Is subject willing to return for scheduled and required study visits? -
Who cannot join
- Patients have a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh.
- Is the patients BMI over 45 kg/m2?
- Is the patient currently pregnant?
- Will undergo a laparoscopic or robotic hernia repair.
- Do they have a class 1 or 4 wound per CDC Guidelines?
- Are they on immunosuppression including medically-induced with>10 mg of prednisone/day?
Show all 15Show fewer
- Do they have a collagen vascular disorder?
- Is patient having a prior mesh removed due to a current active mesh infection? (A synthetic mesh that is not incorporated into the tissue, is extracorporeally exposed or has a chronic draining sinus with clear fluid around the material, but not including synthetic mesh incorporated in abdominal wall and not infected)
- Does the patient have Ascites refractory to medical management?
- Are they in end stage renal (on hemodialysis or peritoneal dialysis) or pre-existing liver disease (Hepatitis B or C or Total Bilirubin >3.0mg/dl)?
- Is the patient severely malnourished as defined by serum albumin<2.0g/dl?
- Do they have a smoking history within 1 month of surgery?
- Does the patient have an objection to the implantation of porcine products?
- Is the subject participating in another clinical study?
- Are unable to undergo successful retro-rectus/preperitoneal mesh placement
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
University of South Carolina School of Medicine
Greenville, South Carolina, 29605
Vanderbilt University
Nashville, Tennessee, 37232
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Prospective Randomized Trial of Biologic Mesh Versus Synthetic Mesh for the Repair of Complex Ventral Hernias
This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of clean-contaminated (Class 2) or contaminated (Class 3) surgical procedures. The findings of this study will have a major impact on the field of hernia surgery as it will provide objective guide to mesh selection, optimize surgical approaches for complex ventral hernia repair, and ultimately significantly improve patient outcomes.
Read the detailed description
This is a multicenter prospective double-blinded randomized controlled trial comparing 253 patients with clean-contaminated (Class 2)or contaminated (Class3) abdominal wall ventral hernias undergoing single staged repair. Soft Mesh by CR Bard, a macroporous monofilament polypropylene permanent mesh will be compared to Strattice mesh by Lifecell, a non-cross linked porcine dermal biologic graft for the single stage open reconstruction of clean-contaminated and contaminated abdominal wall defects. The primary outcome variable will be the absence of surgical site occurence requiring procedural intervention and the absence of a hernia recurrence from the time of surgery up to 24 months of postoperative follow up.
Patients undergoing open ventral hernia repair for clean-contamination and contaminated abdominal wall hernias meeting inclusion criteria will be randomized to receive a synthetic mesh or a biologic mesh. Randomization will be carried out using computer-generated randomization blocks at the time of enrollment. Stratified randomized will be used with the strata formulated by medical center then by clean-contaminated or contaminated surgical site class. The Investigator will be blinded to patient randomization assignment until the point of intra-operative device use following final CDC wound classification, whereas patients and co-investigators responsible for data analysis will remain blinded to patient randomization until the conclusion of the study period. As such, a double-blinded study protocol will be maintained. Patients randomized to synthetic mesh will receive SoftMesh™ (CR Bard, Murray Hill, NJ) and those patients randomized to biologic mesh will receive Strattice™ (Lifecell, Branchburg NJ). The use of biologic and synthetic mesh in contaminated fields is considered experimental however the selection of these prosthetics was based on a careful review of the multiple animal models, preclinical data, and our own clinical experience with each of these materials placed in both clean and contaminated abdominal wall reconstructions. Surgical wounds will be classified based on CDC(Centers for Disease Control) criteria and only Class 2 and 3 wounds will be included in this study.
Postoperatively patients will be evaluated for signs and symptoms of complications along with presence or absence of Surgical Site Infections per CDC guidelines, presence or absence of surgical site occurrences (SSOs) and any procedural interventions required to treat these SSOs, presence or absence of hernia recurrence and any reoperations, length of hospital stay, discharge date, time to return of bowel function and any readmission.
Active participation in this study will last for 24 months and will involve one preoperative evaluation visit, one operative procedure visit, and 4 follow up visits. Participants will complete two brief survey questionnaires regarding quality of life, activities and pain.
The second outcome will be to demonstrate that a macroporous light-weight polypropylene mesh is more cost effective strategy than a biologic prosthetic in clean-contaminated and contaminated abdominal wall reconstruction
- Conditions
- Ventral Hernia
- Being tested
- Davol Bard Soft Mesh synthetic, LifeCell Strattice Reconstructive Tissue Biologic
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Davol Bard Soft Mesh syntheticDevice
soft mesh synthetic
LifeCell Strattice Reconstructive Tissue BiologicDevice
biologic mesh
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Davol Bard ®Soft Mesh | Active comparator | Device: Davol Bard ®Soft Mesh Synthetic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: synthetic mesh SoftMesh™ (CR Bard) Receives: Device: Davol Bard Soft Mesh synthetic |
| Active Comparator: LifeCell Strattice® | Active comparator | Device: LifeCell Strattice® Reconstructive Tissue Matrix Biologic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: Biologic mesh Strattice Receives: Device: LifeCell Strattice Reconstructive Tissue Biologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Absence of Surgical Site Occurrence Requiring Procedural Intervention
Measured: 2 years from surgery
Total Number of Participants With Recurrence of Hernias
Measured: 2 years post surgery
Secondary outcomes (1)
Direct Costs Associated With the Use of Either Polypropylene or Biologic Mesh
Calculate and compare incremental cost effectiveness ratios for patients undergoing repair of clean-contaminated or contaminated ventral hernias using either polypropylene mesh or biologic mesh
Measured: 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startApr 2015
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
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 (3)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Rosen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Rosen, The Cleveland Clinic
- Investigators
- Michael Rosen, MD, Principal investigator, Cleveland Clinic, Cleveland, Ohio, United States, 44195
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451176
- Sponsor's protocol ID
- IRB 14-1571
- Status last verified
- Aug 2022
- First submitted
- 19 May 2015
- Last updated
- 7 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Remulla D, Carvalho A, Birrell AM, Fafaj A, Maskal SM, Woo KP, Bennett WC, Ellis RC, Slatnick BL, Tu C, Prabhu AS, Krpata DM, Petro CC, Beffa LR, Miller BT, Warren JA, Carbonell AM, Poulose BK, Rosen MJ. Mesh-related Outcomes of Biologic Versus Synthetic Mesh for Single-stage Repair of Contaminated Ventral Hernias: A 5 to 10-year Analysis of a Randomized Controlled Trial. Ann Surg. 2026 Mar 1;283(3):390-397. doi: 10.1097/SLA.0000000000006906. Epub 2025 Aug 12.
PubMed 40792628Miller BT, Krpata DM, Petro CC, Beffa LRA, Carbonell AM, Warren JA, Poulose BK, Tu C, Prabhu AS, Rosen MJ. Biologic vs Synthetic Mesh for Parastomal Hernia Repair: Post Hoc Analysis of a Multicenter Randomized Controlled Trial. J Am Coll Surg. 2022 Sep 1;235(3):401-409. doi: 10.1097/XCS.0000000000000275. Epub 2022 Aug 10.
PubMed 35588504Rosen MJ, Krpata DM, Petro CC, Carbonell A, Warren J, Poulose BK, Costanzo A, Tu C, Blatnik J, Prabhu AS. Biologic vs Synthetic Mesh for Single-stage Repair of Contaminated Ventral Hernias: A Randomized Clinical Trial. JAMA Surg. 2022 Apr 1;157(4):293-301. doi: 10.1001/jamasurg.2021.6902.
PubMed 35044431
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Biologic Mesh Versus Synthetic Mesh for the Repair of Complex Ventral Hernias
- ClinicalTrials.gov ID
- NCT02451176
- Acronym / sponsor ID
- IRB 14-1571
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Michael RosenUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Posted 7 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of clean-contaminated (Class 2) or contaminated (Class 3) surgical procedures. The findings of this study will have a major impact on the field of hernia surgery as it will provide objective guide to mesh selection, optimize surgical approaches for complex ventral hernia repair, and ultimately significantly improve patient outcomes.
Detailed description
This is a multicenter prospective double-blinded randomized controlled trial comparing 253 patients with clean-contaminated (Class 2)or contaminated (Class3) abdominal wall ventral hernias undergoing single staged repair. Soft Mesh by CR Bard, a macroporous monofilament polypropylene permanent mesh will be compared to Strattice mesh by Lifecell, a non-cross linked porcine dermal biologic graft for the single stage open reconstruction of clean-contaminated and contaminated abdominal wall defects. The primary outcome variable will be the absence of surgical site occurence requiring procedural intervention and the absence of a hernia recurrence from the time of surgery up to 24 months of postoperative follow up.
Patients undergoing open ventral hernia repair for clean-contamination and contaminated abdominal wall hernias meeting inclusion criteria will be randomized to receive a synthetic mesh or a biologic mesh. Randomization will be carried out using computer-generated randomization blocks at the time of enrollment. Stratified randomized will be used with the strata formulated by medical center then by clean-contaminated or contaminated surgical site class. The Investigator will be blinded to patient randomization assignment until the point of intra-operative device use following final CDC wound classification, whereas patients and co-investigators responsible for data analysis will remain blinded to patient randomization until the conclusion of the study period. As such, a double-blinded study protocol will be maintained. Patients randomized to synthetic mesh will receive SoftMesh™ (CR Bard, Murray Hill, NJ) and those patients randomized to biologic mesh will receive Strattice™ (Lifecell, Branchburg NJ). The use of biologic and synthetic mesh in contaminated fields is considered experimental however the selection of these prosthetics was based on a careful review of the multiple animal models, preclinical data, and our own clinical experience with each of these materials placed in both clean and contaminated abdominal wall reconstructions. Surgical wounds will be classified based on CDC(Centers for Disease Control) criteria and only Class 2 and 3 wounds will be included in this study.
Postoperatively patients will be evaluated for signs and symptoms of complications along with presence or absence of Surgical Site Infections per CDC guidelines, presence or absence of surgical site occurrences (SSOs) and any procedural interventions required to treat these SSOs, presence or absence of hernia recurrence and any reoperations, length of hospital stay, discharge date, time to return of bowel function and any readmission.
Active participation in this study will last for 24 months and will involve one preoperative evaluation visit, one operative procedure visit, and 4 follow up visits. Participants will complete two brief survey questionnaires regarding quality of life, activities and pain.
The second outcome will be to demonstrate that a macroporous light-weight polypropylene mesh is more cost effective strategy than a biologic prosthetic in clean-contaminated and contaminated abdominal wall reconstruction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Davol Bard ®Soft Mesh | Active comparator | Device: Davol Bard Soft Mesh syntheticDevice: Davol Bard ®Soft Mesh Synthetic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: synthetic mesh SoftMesh™ (CR Bard) |
| Active Comparator: LifeCell Strattice® | Active comparator | Device: LifeCell Strattice Reconstructive Tissue BiologicDevice: LifeCell Strattice® Reconstructive Tissue Matrix Biologic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: Biologic mesh Strattice |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject is > 21 years of age (including women of childbearing age)
- Scheduled to undergo a planned open single stage reconstruction of a contaminated (CDC wound class2 or 3) abdominal wall defect
- Ability to undergo general anesthesia
- Is willing and able to give informed consent
- Is this a clean-contaminated (Class 2) or contaminated (Class 3) case per CDC Guidelines?
Key exclusion criteria (15 listed)
- Patients have a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh.
- Is the patients BMI over 45 kg/m2?
- Is the patient currently pregnant?
- Will undergo a laparoscopic or robotic hernia repair.
- Do they have a class 1 or 4 wound per CDC Guidelines?
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 |
|---|---|---|
| Davol Bard Soft Mesh syntheticsoft mesh synthetic | Device | Active Comparator: Davol Bard ®Soft Mesh |
| LifeCell Strattice Reconstructive Tissue Biologicbiologic mesh | Device | Active Comparator: LifeCell Strattice® |
Primary outcome
Number of Participants With Absence of Surgical Site Occurrence Requiring Procedural Intervention
Time frame: 2 years from surgery
Total Number of Participants With Recurrence of Hernias
Time frame: 2 years post surgery
1 secondary outcome
Direct Costs Associated With the Use of Either Polypropylene or Biologic Mesh
Time frame: 30 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40792628Remulla D, Carvalho A, Birrell AM, Fafaj A, Maskal SM, Woo KP, Bennett WC, Ellis RC, Slatnick BL, Tu C, Prabhu AS, Krpata DM, Petro CC, Beffa LR, Miller BT, Warren JA, Carbonell AM, Poulose BK, Rosen MJ. Mesh-related Outcomes of Biologic Versus Synthetic Mesh for Single-stage Repair of Contaminated Ventral Hernias: A 5 to 10-year Analysis of a Randomized Controlled Trial. Ann Surg. 2026 Mar 1;283(3):390-397. doi: 10.1097/SLA.0000000000006906. Epub 2025 Aug 12.
- Derived from this study: PubMed 35588504Miller BT, Krpata DM, Petro CC, Beffa LRA, Carbonell AM, Warren JA, Poulose BK, Tu C, Prabhu AS, Rosen MJ. Biologic vs Synthetic Mesh for Parastomal Hernia Repair: Post Hoc Analysis of a Multicenter Randomized Controlled Trial. J Am Coll Surg. 2022 Sep 1;235(3):401-409. doi: 10.1097/XCS.0000000000000275. Epub 2022 Aug 10.
- Derived from this study: PubMed 35044431Rosen MJ, Krpata DM, Petro CC, Carbonell A, Warren J, Poulose BK, Costanzo A, Tu C, Blatnik J, Prabhu AS. Biologic vs Synthetic Mesh for Single-stage Repair of Contaminated Ventral Hernias: A Randomized Clinical Trial. JAMA Surg. 2022 Apr 1;157(4):293-301. doi: 10.1001/jamasurg.2021.6902.
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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.
Michael Rosen, MD principal investigator
Cleveland Clinic, Cleveland, Ohio, United States, 44195
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Davol Bard Soft Mesh synthetic and LifeCell Strattice Reconstructive Tissue Biologic in people with Ventral Hernia, run by Michael Rosen at 4 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 8 inclusion and 15 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 7 Sep 2022). 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 Participants With Absence of Surgical Site Occurrence Requiring Procedural Intervention (time frame: 2 years from surgery). The study lists 2 primary outcomes in all. 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 NCT02451176, which also lists 3 linked publications.
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 7 Sep 2022.