Ventral HerniaDavolNCT01295125
Comparative Study of Biologic Mesh Versus Repair With Component Separation.
A study testing XenMATRIX mesh and Open abdominal ventral hernia repair in people with Ventral Hernia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare open abdominal incisional hernia repair using XenMATRIX biologic mesh versus repair with their own tissue. This study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- XenMATRIX mesh and Open abdominal ventral hernia repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is an adult ≥ 18 years old of either gender
- Will undergo a planned open abdominal incisional hernia repair
- Has a defect that can be repaired primarily without tension with myofascial advancement flaps and requires no more than 1 piece of surgical mesh (largest mesh size (19 x 35 cm)
- Contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction with a bowel resection, or such contaminations occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus
- Infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh
- Has an estimated hernia size of ≥ 3cm to 20cm in maximal width by physical exam
Show all 9Show fewer
- Is considered a clean-contaminated or contaminated case per Surgical Site Infection Risk Guidelines
- Is willing and able to return for all scheduled and required study visits
- Is willing and able to provide written informed consent for study participation
Who cannot join
- Has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh
- Is a clean or dirty case per Surgical Site Infection Risk Guidelines
- Has conditions that would adversely affect subject safety as per product labeling
- Will undergo a laparoscopic hernia repair
- Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh
- Has conditions which preclude abdominal imaging at a standard imaging facility
Show all 12Show fewer
- Has an anticipated survival of < 24 months
- Care plan is to perform a staged repair over 45 days
- Is bedridden or otherwise non-ambulatory (i.e. is unable to independently transfer into and out of a wheelchair)
- Is ASA class 4 or 5
- BMI over 45
- Is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Randomized Control Trial of Biologic Mesh (XenMATRIXTM) vs. Component Separation Alone in Contaminated Ventral Hernia Repair:a Pilot Study
The purpose of this study is to compare open abdominal incisional hernia repair using XenMATRIX biologic mesh versus repair with their own tissue. This study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia.
Read the detailed description
This study will involve comparison of open abdominal incisional hernia repair with XenMATRIX biologic graft versus repair with native tissue.
The current study seeks to evaluate XenMATRIXTM, an FDA approved biologic graft for repairing contaminated abdominal wall defects.
This study will provide significant insight for the reconstructive surgeon and patient to determine whether a biologic graft is necessary for the reconstruction of a contaminated ventral hernia repair to provide a durable single staged repair.
- Conditions
- Ventral Hernia
- Being tested
- XenMATRIX mesh, Open abdominal ventral hernia repair
- Keywords
- Infected ventral hernia, Contaminated incisional hernia
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenMATRIX meshDevice
Also called Davol Biologic mesh
Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair
Open abdominal ventral hernia repairProcedure or surgery
Also called Abdominal ventral hernia repair with native tissue
Abdominal ventral hernia repair with native tissue
| Study group | Role | What they receive |
|---|---|---|
| XenMATRIX | Experimental | Use of XenMATRIX mesh to repair hernia Receives: Device: XenMATRIX mesh; Procedure: Open abdominal ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Postoperative Hernia Recurrence
Measured: two years after surgery date
Secondary outcomes (5)
Compare the Short-term Clinical Outcomes of Postoperative Wound Events
Measured: two years after surgery date
Length of Hospital Stay
Participants will be followed for the duration of the hospital stay, an expected average of 1 week
Measured: Number of days up to 1 week
Length of Resource Utilization
Measured: two years after surgery date
Antibiotic Usage and Days
Measured: two years after surgery date
Resumption of Activities of Daily Living
Measured: two years after surgery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Sponsor chose not to move forward with study
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bard Ltd
- Responsible party
- Sponsor
- Investigators
- Michael J. Rosen, MD., Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295125
- Sponsor's protocol ID
- 11-10-23
- Acronym
- Davol
- Status last verified
- Jan 2023
- First submitted
- 11 Feb 2011
- Last updated
- 25 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Biologic Mesh (XenMATRIXTM) vs. Component Separation Alone in Contaminated Ventral Hernia Repair:a Pilot Study
- ClinicalTrials.gov ID
- NCT01295125
- Acronym / sponsor ID
- Davol / 11-10-23
- Conditions
- Ventral Hernia
- Keywords
- Infected ventral hernia, Contaminated incisional hernia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor chose not to move forward with study
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Bard Ltd
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Posted 25 Jan 2023
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 open abdominal incisional hernia repair using XenMATRIX biologic mesh versus repair with their own tissue. This study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia.
Detailed description
This study will involve comparison of open abdominal incisional hernia repair with XenMATRIX biologic graft versus repair with native tissue.
The current study seeks to evaluate XenMATRIXTM, an FDA approved biologic graft for repairing contaminated abdominal wall defects.
This study will provide significant insight for the reconstructive surgeon and patient to determine whether a biologic graft is necessary for the reconstruction of a contaminated ventral hernia repair to provide a durable single staged repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XenMATRIX | Experimental | Device: XenMATRIX mesh, Procedure: Open abdominal ventral hernia repairUse of XenMATRIX mesh to repair hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is an adult ≥ 18 years old of either gender
- Will undergo a planned open abdominal incisional hernia repair
- Has a defect that can be repaired primarily without tension with myofascial advancement flaps and requires no more than 1 piece of surgical mesh (largest mesh size (19 x 35 cm)
- Contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction with a bowel resection, or such contaminations occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus
- Infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh
Key exclusion criteria (12 listed)
- Has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh
- Is a clean or dirty case per Surgical Site Infection Risk Guidelines
- Has conditions that would adversely affect subject safety as per product labeling
- Will undergo a laparoscopic hernia repair
- Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh
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 |
|---|---|---|
| XenMATRIX meshAlso: Davol Biologic meshUse of XenMATRIX mesh in the repair of contaminated ventral hernia repair | Device | XenMATRIX |
| Open abdominal ventral hernia repairAlso: Abdominal ventral hernia repair with native tissueAbdominal ventral hernia repair with native tissue | Procedure or surgery | XenMATRIX |
Primary outcome
The Incidence of Postoperative Hernia Recurrence
Time frame: two years after surgery date
5 secondary outcomes
Compare the Short-term Clinical Outcomes of Postoperative Wound Events
Time frame: two years after surgery date
Length of Hospital Stay
Time frame: Number of days up to 1 week
Length of Resource Utilization
Time frame: two years after surgery date
Antibiotic Usage and Days
Time frame: two years after surgery date
Resumption of Activities of Daily Living
Time frame: two years after surgery date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ventral Hernia
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Preoperative BOTOX® Injection for Large Ventral Hernia Repair
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Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
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The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
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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 J. Rosen, MD. principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XenMATRIX mesh and Open abdominal ventral hernia repair in people with Ventral Hernia, run by University Hospitals Cleveland Medical Center 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 9 inclusion and 12 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 25 Jan 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?
Yes. Results are posted in the registry (first posted 25 Jan 2023). 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?
The Incidence of Postoperative Hernia Recurrence (time frame: two years after surgery date). 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 25 Jan 2023; AzTrials last refreshed its copy on 31 Oct 2026.