Hernia, VentralNCT02228889
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
A study testing Abdominal wall reconstruction with Strattice, Assess pain intensity at last office visit preoperatively and Assess pain interference at last office visit preoperatively in people with Hernia, Ventral and Intestinal Fistula, run by Jeffrey Janis at 1 site in United States.
Trial summary
The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hernia, Ventral, Intestinal Fistula, Fibromatosis, Abdominal
- What is being tested?
- Abdominal wall reconstruction with Strattice, Assess pain intensity at last office visit preoperatively and Assess pain interference at last office visit preoperatively
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 27 Mar 2025
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Patients presenting for elective hernia repair, with Ventral Hernia Working Group (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia size, discomfort, risk of bowel incarceration, effect on physical function), and who have comorbidities or contamination making the use of synthetic mesh contraindicated)
- Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who can have a major surgical procedure without an exceedingly high risk of medical complications such as pulmonary edema, myocardial infarction, pulmonary embolism, renal failure, life-threatening bleeding, stroke).
- Patients presenting for resection of large abdominal wall tumors who are expected to undergo have tumor extirpative defect that would require biologic mesh for closure (patients with a large tumor of the abdominal wall who will have a large defect in their fascia after resection, who need biologic mesh for reinforcement).
Who cannot join
- Known allergy to porcine products
- Active smokers (within the past 4 weeks) presenting for elective hernia repair
- Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective hernia repair
- Patients presenting for emergent hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively
- Patients with severe systemic sepsis
- Patients with frank purulence in the wound
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction
The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.
Read the detailed description
This is a prospective, randomized-controlled trial comparing two porcine acellular matrices in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of mesh used while surgeons are not).
Our goals in this study are:
- PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively
- SECONDARY OUTCOMES
- To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days and 1 year postoperatively
- Infection
- Seroma
- Hematoma
- Wound dehiscence
- Skin necrosis
- Formation of enterocutaneous fistula
- Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient pain, physical functioning and quality of life after hernia repair between XenMatrix and Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C. Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey
- Conditions
- Hernia, Ventral, Intestinal Fistula, Fibromatosis, Abdominal
- Being tested
- Abdominal wall reconstruction with Strattice, Assess pain intensity at last office visit preoperatively, Assess pain interference at last office visit preoperatively, Assess physical functioning at last office visit preoperatively, Assess patient quality of life at last office visit preoperatively
- Keywords
- Hernia, Abdominal wall reconstruction, Abdominal wall defect, Porcine mesh, Component separation, Abdominal wall tumor, Desmoid
- Medical subject headings
- Hernia, Ventral, Intestinal Fistula, Fibromatosis, Abdominal, Hernia, Peritoneal Neoplasms, Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal wall reconstruction with StratticeProcedure or surgery
Abdominal wall reconstruction using Strattice
Assess pain intensity at last office visit preoperativelyOther
Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
Assess pain interference at last office visit preoperativelyOther
Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
Assess physical functioning at last office visit preoperativelyOther
Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
Assess patient quality of life at last office visit preoperativelyOther
Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
Assess patient pain intensity postoperativelyOther
Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
Assess pain interference postoperativelyOther
Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
Assess physical functioning postoperativelyOther
Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
Assess quality of life postoperativelyOther
Assess quality of life at 1 year postoperatively using the HerQLes survey
Assess hernia recurrence at 30 days postoperativelyOther
Assess hernia recurrence at 30 days
Assess bulge at 30 days postoperativelyOther
Assess bulge at 30 days
Assess Surgical Site Occurrences at 30 days postoperativelyOther
Assess Surgical Site Occurrences at 30 days
Assess hernia recurrence at 1 year postoperativelyOther
Assess hernia recurrence at 1 year postoperatively
Assess bulge at 1 year postoperativelyOther
Assess bulge at 1 year postoperatively
Assess Surgical Site Occurrences at 1 year postoperativelyOther
Assess Surgical Site Occurrences at 1 year postoperatively
Assess overall complications at 30 days postoperativelyOther
Assess overall complications at 1 year postoperativelyOther
Abdominal wall reconstruction with XenMatrixProcedure or surgery
Abdominal wall reconstruction with XenMatrix
StratticeDevice
Strattice mesh
XenMatrixDevice
Xenmatrix mesh
| Study group | Role | What they receive |
|---|---|---|
| Strattice | Experimental | Abdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively Receives: Procedure: Abdominal wall reconstruction with Strattice; Other: Assess pain intensity at last office visit preoperatively; Other: Assess pain interference at last office visit preoperatively; Other: Assess physical functioning at last office visit preoperatively; Other: Assess patient quality of life at last office visit preoperatively; Other: Assess patient pain intensity postoperatively; Other: Assess pain interference postoperatively; Other: Assess physical functioning postoperatively; Other: Assess quality of life postoperatively; Other: Assess hernia recurrence at 30 days postoperatively; Other: Assess bulge at 30 days postoperatively; Other: Assess Surgical Site Occurrences at 30 days postoperatively; Other: Assess hernia recurrence at 1 year postoperatively; Other: Assess bulge at 1 year postoperatively; Other: Assess Surgical Site Occurrences at 1 year postoperatively; Other: Assess overall complications at 30 days postoperatively; Other: Assess overall complications at 1 year postoperatively; Device: Strattice |
| XenMatrix | Experimental | Abdominal wall reconstruction with XenMatrix Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively Receives: Other: Assess pain intensity at last office visit preoperatively; Other: Assess pain interference at last office visit preoperatively; Other: Assess physical functioning at last office visit preoperatively; Other: Assess patient quality of life at last office visit preoperatively; Other: Assess patient pain intensity postoperatively; Other: Assess pain interference postoperatively; Other: Assess physical functioning postoperatively; Other: Assess quality of life postoperatively; Other: Assess hernia recurrence at 30 days postoperatively; Other: Assess bulge at 30 days postoperatively; Other: Assess Surgical Site Occurrences at 30 days postoperatively; Other: Assess hernia recurrence at 1 year postoperatively; Other: Assess bulge at 1 year postoperatively; Other: Assess Surgical Site Occurrences at 1 year postoperatively; Other: Assess overall complications at 30 days postoperatively; Other: Assess overall complications at 1 year postoperatively; Procedure: Abdominal wall reconstruction with XenMatrix; Device: XenMatrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Surgical Site Occurrences (SSOs) at 6 Week
Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include:
- Infection
- Seroma
- Hematoma
- Wound dehiscence
- Skin necrosis
- Formation of enterocutaneous fistula
- Mesh infection
Measured: 6 week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startJan 2015
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
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
- Model description
- Abdominal wall reconstruction using Strattice
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Janis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey Janis, Ohio State University
- Investigators
- Jeffrey E Janis, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228889
- Sponsor's protocol ID
- 2014H0041
- Status last verified
- May 2025
- First submitted
- 18 Aug 2014
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Elemosho A, Sarac BA, Olson MA, Khansa I, Hackenberger PN, Narula V, Eiferman DS, Janis JE. Comparative Outcomes of Two Non-Crosslinked Porcine Acellular Dermal Matrices in Complex Abdominal Wall Reconstruction: A Randomized Controlled Trial and an Observational Cohort Study. World J Surg. 2026 Apr;50(4):848-859. doi: 10.1002/wjs.70271. Epub 2026 Feb 20.
PubMed 41720620
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction
- ClinicalTrials.gov ID
- NCT02228889
- Acronym / sponsor ID
- 2014H0041
- Conditions
- Hernia, Ventral, Intestinal Fistula, Fibromatosis, Abdominal
- Keywords
- Hernia, Abdominal wall reconstruction, Abdominal wall defect, Porcine mesh, Component separation, Abdominal wall tumor, Desmoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Jeffrey JanisUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Posted 6 Jun 2025
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 the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.
Detailed description
This is a prospective, randomized-controlled trial comparing two porcine acellular matrices in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of mesh used while surgeons are not).
Our goals in this study are:
- PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively
- SECONDARY OUTCOMES
- To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days and 1 year postoperatively
- Infection
- Seroma
- Hematoma
- Wound dehiscence
- Skin necrosis
- Formation of enterocutaneous fistula
- Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient pain, physical functioning and quality of life after hernia repair between XenMatrix and Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C. Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Abdominal wall reconstruction using Strattice
| Arm | Type | Receives |
|---|---|---|
| Strattice | Experimental | Procedure: Abdominal wall reconstruction with Strattice, Other: Assess pain intensity at last office visit preoperatively, Other: Assess pain interference at last office visit preoperatively, Other: Assess physical functioning at last office visit preoperatively, Other: Assess patient quality of life at last office visit preoperatively, Other: Assess patient pain intensity postoperatively, Other: Assess pain interference postoperatively, Other: Assess physical functioning postoperatively, Other: Assess quality of life postoperatively, Other: Assess hernia recurrence at 30 days postoperatively, Other: Assess bulge at 30 days postoperatively, Other: Assess Surgical Site Occurrences at 30 days postoperatively, Other: Assess hernia recurrence at 1 year postoperatively, Other: Assess bulge at 1 year postoperatively, Other: Assess Surgical Site Occurrences at 1 year postoperatively, Other: Assess overall complications at 30 days postoperatively, Other: Assess overall complications at 1 year postoperatively, Device: StratticeAbdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively |
| XenMatrix | Experimental | Other: Assess pain intensity at last office visit preoperatively, Other: Assess pain interference at last office visit preoperatively, Other: Assess physical functioning at last office visit preoperatively, Other: Assess patient quality of life at last office visit preoperatively, Other: Assess patient pain intensity postoperatively, Other: Assess pain interference postoperatively, Other: Assess physical functioning postoperatively, Other: Assess quality of life postoperatively, Other: Assess hernia recurrence at 30 days postoperatively, Other: Assess bulge at 30 days postoperatively, Other: Assess Surgical Site Occurrences at 30 days postoperatively, Other: Assess hernia recurrence at 1 year postoperatively, Other: Assess bulge at 1 year postoperatively, Other: Assess Surgical Site Occurrences at 1 year postoperatively, Other: Assess overall complications at 30 days postoperatively, Other: Assess overall complications at 1 year postoperatively, Procedure: Abdominal wall reconstruction with XenMatrix, Device: XenMatrixAbdominal wall reconstruction with XenMatrix Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18
- Patients presenting for elective hernia repair, with Ventral Hernia Working Group (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia size, discomfort, risk of bowel incarceration, effect on physical function), and who have comorbidities or contamination making the use of synthetic mesh contraindicated)
- Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who can have a major surgical procedure without an exceedingly high risk of medical complications such as pulmonary edema, myocardial infarction, pulmonary embolism, renal failure, life-threatening bleeding, stroke).
- Patients presenting for resection of large abdominal wall tumors who are expected to undergo have tumor extirpative defect that would require biologic mesh for closure (patients with a large tumor of the abdominal wall who will have a large defect in their fascia after resection, who need biologic mesh for reinforcement).
Key exclusion criteria (6 listed)
- Known allergy to porcine products
- Active smokers (within the past 4 weeks) presenting for elective hernia repair
- Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective hernia repair
- Patients presenting for emergent hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively
- Patients with severe systemic sepsis
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 |
|---|---|---|
| Abdominal wall reconstruction with StratticeAbdominal wall reconstruction using Strattice | Procedure or surgery | Strattice |
| Assess pain intensity at last office visit preoperativelyAssess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively) | Other | Strattice, XenMatrix |
| Assess pain interference at last office visit preoperativelyAssess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively) | Other | Strattice, XenMatrix |
| Assess physical functioning at last office visit preoperativelyAssess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively) | Other | Strattice, XenMatrix |
| Assess patient quality of life at last office visit preoperativelyAssess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively) | Other | Strattice, XenMatrix |
| Assess patient pain intensity postoperativelyAssess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey | Other | Strattice, XenMatrix |
| Assess pain interference postoperativelyAssess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey | Other | Strattice, XenMatrix |
| Assess physical functioning postoperativelyAssess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey | Other | Strattice, XenMatrix |
| Assess quality of life postoperativelyAssess quality of life at 1 year postoperatively using the HerQLes survey | Other | Strattice, XenMatrix |
| Assess hernia recurrence at 30 days postoperativelyAssess hernia recurrence at 30 days | Other | Strattice, XenMatrix |
| Assess bulge at 30 days postoperativelyAssess bulge at 30 days | Other | Strattice, XenMatrix |
| Assess Surgical Site Occurrences at 30 days postoperativelyAssess Surgical Site Occurrences at 30 days | Other | Strattice, XenMatrix |
| Assess hernia recurrence at 1 year postoperativelyAssess hernia recurrence at 1 year postoperatively | Other | Strattice, XenMatrix |
| Assess bulge at 1 year postoperativelyAssess bulge at 1 year postoperatively | Other | Strattice, XenMatrix |
| Assess Surgical Site Occurrences at 1 year postoperativelyAssess Surgical Site Occurrences at 1 year postoperatively | Other | Strattice, XenMatrix |
| Assess overall complications at 30 days postoperatively | Other | Strattice, XenMatrix |
| Assess overall complications at 1 year postoperatively | Other | Strattice, XenMatrix |
| Abdominal wall reconstruction with XenMatrixAbdominal wall reconstruction with XenMatrix | Procedure or surgery | XenMatrix |
| StratticeStrattice mesh | Device | Strattice |
| XenMatrixXenmatrix mesh | Device | XenMatrix |
Primary outcome
Rate of Surgical Site Occurrences (SSOs) at 6 Week
Time frame: 6 week postoperatively
Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include: 1. Infection 2. Seroma 3. Hematoma 4. Wound dehiscence 5. Skin necrosis 6. Formation of enterocutaneous fistula 7. Mesh infection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41720620Elemosho A, Sarac BA, Olson MA, Khansa I, Hackenberger PN, Narula V, Eiferman DS, Janis JE. Comparative Outcomes of Two Non-Crosslinked Porcine Acellular Dermal Matrices in Complex Abdominal Wall Reconstruction: A Randomized Controlled Trial and an Observational Cohort Study. World J Surg. 2026 Apr;50(4):848-859. doi: 10.1002/wjs.70271. Epub 2026 Feb 20.
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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.
Jeffrey E Janis, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal wall reconstruction with Strattice, Assess pain intensity at last office visit preoperatively and Assess pain interference at last office visit preoperatively in people with Hernia, Ventral and Intestinal Fistula, run by Jeffrey Janis 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 4 inclusion and 6 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 6 Jun 2025. 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 6 Jun 2025). 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?
Rate of Surgical Site Occurrences (SSOs) at 6 Week (time frame: 6 week postoperatively). 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 NCT02228889, 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 6 Jun 2025.