N/A
N=75
Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias
Incisional Hernia
Bottom Line
View on ClinicalTrials.gov: NCT02691962 ↗Enrolled (actual)
75
Serious AEs
41.3%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants With Wound Occurrences Up to 45 Days Post Implantation — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Xen Matrix AB (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Wound Occurrences Up to 45 Days Post Implantation |
11 | — |
| SECONDARY Number of Participants With Wound Occurrences > 45 Days Post Implantation |
15 | — |
| SECONDARY Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure |
0; 4 | — |
| SECONDARY Number of Participants With Reoperation Due to Index Hernia Repair |
8 | — |
| SECONDARY Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure |
1.6; 1.4; 1.2; 0.9; 0.8; 0.8 | — |
| SECONDARY General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation. |
47.7; 47.2; 48.6; 48.3; 48.3; 49.4 | — |
| SECONDARY Number of Participants Who Returned to Work Post Implantation Procedure |
17 | — |
| SECONDARY Duration of Participants Stay in Hospital Following Implantation Procedure |
6.7 | — |
Summary
This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes ("All Comers") through 24 months post repair.
Eligibility Criteria
Inclusion Criteria
- Subject must be willing and able to give written informed consent.
- Subject must be diagnosed with a ventral or incisional midline hernia.
- Mesh must be placed in the retro-rectus or intraperitoneal plane.
- Subject must be willing to undergo open hernia repair and be able to undergo all other study procedures as outlined in this protocol.
Exclusion Criteria
- The use of surgical graft as a bridge repair.
- The subject has more than 4 prior recurrences.
- Subject has a contraindication for the placement of surgical graft.
- Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
- The study hernia repair requires more than a single piece mesh (including sufficient overlap beyond margins of the defect on all sides).
- Subject has intact permanent mesh adjacent to the current hernia to be repaired.
- Subject has peritonitis at the time of surgery.
- The subject is an active smoker within the last 2 weeks prior to surgery.
- Clinically significant Chronic Obstructive Pulmonary Disease or heart failure, defined as marked limitation in ability or inability to perform activities of daily living.
- Subject had chemotherapy within the last 12 months, is on or suspected to be placed on chemotherapy medications during any part of the study.
- Chronic steroid use (>6 months) or immunosuppression drugs.
- Subject's body mass index (BMI) >45 kg/m2.
- Subject has cirrhosis, and/or ascites.
- Subject has a defined collagen disorder.
- Known to be infected with human immunodeficiency virus (HIV).
- Subject has clinically significant (not based solely on creatinine levels) kidney disease that limits Activities of Daily Living, is on hemodialysis or peritoneal dialysis.
- Subject is American Society of Anesthesiology (ASA) Class 4 or 5.
- Subject has a life expectancy < 2 years at the time of enrollment.
- Subject is pregnant, breastfeeding or planning on becoming pregnant during the course of the study.
- Subjects with known sensitivity to porcine products.
- Subjects with allergy, history of allergy or hypersensitivity to tetracyclines (including minocycline) or rifamycins (including rifampin).
- Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
Data sourced from ClinicalTrials.gov (NCT02691962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.