Trials / Completed
CompletedNCT02691962
Xen Matrix™ AB Surgical Graft in Ventral or Incisional Midline Hernias
A Post-Market, Prospective, Multicenter, Single-Arm Trial of XenMatrix™ AB Surgical Graft in All Wound Classes Ventral or Incisional Midline Hernias
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a post-market, on-label study to understand the performance of the graft in the US.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Xen Matrix AB | 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. |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2020-05-01
- Completion
- 2020-05-01
- First posted
- 2016-02-25
- Last updated
- 2021-10-21
- Results posted
- 2021-10-21
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02691962. Inclusion in this directory is not an endorsement.