Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias (NCT02691962) | Clinical Trial Compass
CompletedNot Applicable
Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias
United States75 participantsStarted 2016-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 defin…
What they're measuring
1
Number of Participants With Wound Occurrences Up to 45 Days Post Implantation