An interventional study of Abdominal wall reconstruction with Strattice and Assess pain intensity at last office visit preoperatively in Hernia, Ventral, Intestinal Fistula and Fibromatosis, Abdominal, sponsored by Jeffrey Janis. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Jeffrey Janis · Not applicable, Interventional, and Treatment
Among 94 studies in Hernia, Ventral with a site in United States — 14 open to participants now, 25 under way, none of them phase 3. Hernia, Ventral · United States.
Among the 94 studies in Hernia, Ventral with a site in United States, this one is the 47th largest by enrollment of the 70 interventional ones, is one of 8 that started in 2015, is one of 57 with no phase, and was the 25th registered.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's enrollment of 46 is below the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →14 of the 94 studies in Hernia, Ventral with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 26 Hernia, Ventral studies recruiting now, 19 (73%) set no upper age limit and 4 (15%) stop at 75 or younger; 1 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →94 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 8 started in 2015.
Median enrollment 100 across the 70 interventional studies, 63 across the 24 observational. Of the 58 that completed or were terminated, 31 (53%) have results posted.
32 of 94 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Jeffrey Janis as lead sponsor.
Jeffrey Janis has 1 study filed under Hernia, Ventral — fewer than ten, so there is no comparison to draw.
10 of the studies in Hernia, Ventral with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04718168W.L.Gore & AssociatesGORE® ENFORM Biomaterial Product Study | 2026-12 |
| NCT07639281Tori DotsonOpioid Education Ventral Hernia Repair | 2026-12 |
| NCT07874724University of South FloridaCryoneurolysis for Abdominal Wall Relaxation Prior to Ventral Hernia Repair | 2027-03-01 |
| NCT04779918Tela Bio IncVentral or Inguinal Hernia, Robotically Repaired With OviTex Mesh | 2027-03-30 |
| NCT06874413Prisma Health-UpstateTargeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Ventral Hernia Repair | 2027-04-30 |
Among the 94 studies in Hernia, Ventral with a site in United States, from their registry updates:
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.
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:
i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days and 1 year postoperatively
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Abdominal wall reconstruction using Strattice
Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
Assess quality of life at 1 year postoperatively using the HerQLes survey
Assess hernia recurrence at 30 days
Assess bulge at 30 days
Assess Surgical Site Occurrences at 30 days
Assess hernia recurrence at 1 year postoperatively
Assess bulge at 1 year postoperatively
Assess Surgical Site Occurrences at 1 year postoperatively
Abdominal wall reconstruction with XenMatrix
Strattice mesh
Xenmatrix mesh
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: 1. Infection 2. Seroma 3. Hematoma 4. Wound dehiscence 5. Skin necrosis 6. Formation of enterocutaneous fistula 7. Mesh infection
Time frame: 6 week postoperatively
| Milestone | Strattice | XenMatrix |
|---|---|---|
| Started | 16 | 30 |
| Completed | 16 | 30 |
| Not completed | 0 | 0 |
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
| event | Strattice | XenMatrix |
|---|---|---|
| Rate of Surgical Site Occurrences (SSOs) at 6 Week | 1 ± 6.25 | 11 ± 36.67 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Strattice | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| XenMatrix | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
Enrollment was stopped prior to the pre-determined 70 total participants, as a shift in practice and national trend toward the use of synthetic mesh over biologic mesh hindered participant recruitment.
| Age, Continuous(years) | Strattice | XenMatrix | Total |
|---|---|---|---|
| Median | 60 (55.8 to 68.6) | 57 (43 to 62.1) | 60 (43 to 68) |
| Sex: Female, Male(Participants) | Strattice | XenMatrix | Total |
|---|---|---|---|
| Female | 10 | 14 | 24 |
| Male | 6 | 16 | 22 |
| Race and Ethnicity Not Collected(Participants) | Strattice | XenMatrix | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Body Mass Index(kg/m^2) | Strattice | XenMatrix | Total |
|---|---|---|---|
| Median | 29.6 (26.8 to 33.5) | 33.1 (26.5 to 37.4) | 33.1 (26.4 to 37.3) |
| Number of prior Hernia Repairs(prior repairs) | Strattice | XenMatrix | Total |
|---|---|---|---|
| Median | 2.5 (0 to 9) | 1 (0 to 2) | 1 (0 to 4.5) |
| Hernia Width(cm) | Strattice | XenMatrix | Total |
|---|---|---|---|
| Median | 15.8 (10 to 18.7) | 12.9 (9.5 to 18.7) | 12.9 (9.48 to 18.71) |
| Diabetes(Participants) | Strattice | XenMatrix | Total |
|---|---|---|---|
| Count of participants | 7 | 7 | 14 |
| Hypertension(Participants) | Strattice | XenMatrix | Total |
|---|---|---|---|
| Count of participants | 7 | 14 | 21 |
10 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2015 to primary completion in Mar 2025, 122 months.
Results were first posted in Jun 2025, 2 months after primary completion.
Of 75 non-industry interventional studies with no phase under Hernia, Ventral, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's 122 months is above that.
Counting every sponsor, half of 88 studies reached it within 37 months; a quarter within 19 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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