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N/A N=75 Treatment

Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias

Incisional Hernia

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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