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.
This is a post-market, on-label study to understand the performance of the graft in the US.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Xen Matrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed dry for use in the reconstruction of soft tissue deficiencies. The device surfaces are coated with the antibacterial agents Rifampin and Minocycline in a bioresorbable L-Tyrosine succinate polymer carrier.
Keck Hospital of USC
Los Angeles, California, United States
California Pacific Medical Center - Sutter Health
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Number of Participants With Wound Occurrences Up to 45 Days Post Implantation
Wound occurrences were defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.
Time frame: Up to 45 days post implantation
Number of Participants With Wound Occurrences > 45 Days Post Implantation
Wound occurrences was defined as surgical site infection, seroma, wound dehiscence, skin necrosis and fistulas requiring intervention.
Time frame: Day 45 and up to 2 years post implantation
Number of Participants With Hernia Recurrence Within 6 Months and 24 Months of Implantation Procedure
Time frame: Within 6 months and 24 months of implantation procedure
Number of Participants With Reoperation Due to Index Hernia Repair
Time frame: 24 months post implantation procedure
Total Score on the Carolinas Comfort Scale (CCS) at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation Procedure
The Carolinas Comfort Scale (CCS) quality of life questionnaire aimed for patients who have had hernia repair surgery. Symptoms in the CCS are rated by the participants on a scale of 0 to 5, with a score of 0 suggesting no symptoms and a score of 5, disabling symptoms. A lower score on the questionnaire compared to baseline would indicate a better outcome.
Time frame: Baseline, 1, 3, 6, 12, 18, and 24 months post implantation procedure
General Health Score on the Short Form 12 (SF-12) Questionnaire at Baseline, 1, 3, 6, 12, 18, and 24 Months Post Implantation.
The Short Form 12 (SF-12) is a self-reported 12-item questionnaire that evaluates general health and well-being (overall quality of life of an individual). The SF-12 includes questions on physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating better levels of functioning.
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Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
...and 1 more locations
Time frame: Baseline, 1, 3, 6, 12, 18, and 24 months post implantation
Number of Participants Who Returned to Work Post Implantation Procedure
Time frame: Up to 2 years following implantation procedure
Duration of Participants Stay in Hospital Following Implantation Procedure
Time frame: From index procedure day to discharge from hospital day