An interventional study of XenMATRIX mesh and Open abdominal ventral hernia repair in Ventral Hernia, sponsored by University Hospitals Cleveland Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
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.
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 9 is below the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of XenMATRIX mesh to repair hernia
Device: XenMATRIX mesh · Procedure: Open abdominal ventral hernia repair
Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair
Also known as: Davol Biologic mesh
Abdominal ventral hernia repair with native tissue
Also known as: Abdominal ventral hernia repair with native tissue
The Incidence of Postoperative Hernia Recurrence
Time frame: two years after surgery date
Compare the Short-term Clinical Outcomes of Postoperative Wound Events
Time frame: 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
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
| Milestone | XenMATRIX |
|---|---|
| Started | 9 |
| Completed | 0 |
| Not completed | 9 |
| Withdrew: Study stopped prematurely | 9 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Participants will be followed for the duration of the hospital stay, an expected average of 1 week
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over AE data not collected. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| XenMATRIX | — | — | — |
| Age, Categorical(Participants) | XenMATRIX |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 9 |
| Sex: Female, Male(Participants) | XenMATRIX |
|---|---|
| Female | 4 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | XenMATRIX |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University Hospitals Cleveland Medical Center