NCT04986943

ABTHERA ADVANCE™ Use Without Wittman Patch

Use of the ABTHERA ADVANCE™ Open Abdomen Dressing in Patients With Necrotizing Pancreatitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: —

Summary

The objective of this study is to evaluate the use of the ABTHERA ADVANCE for patients requiring open abdomen due to necrotizing pancreatitis. The institutions traditional approach is to use the ABTHERA Open Abdomen dressing with Wittmann patch. However, the ABTHERA ADVANCE has shown in vitro to have improved tension on the abdominal wall that may obviate the need for costly Wittmann patch placement.

Detailed description

The objective of this study is to evaluate the use of the ABTHERA ADVANCE for patients requiring open abdomen due to necrotizing pancreatitis. The instiutions traditional approach is to use the ABTHERA Open Abdomen dressing with Wittmann patch. However, the ABTHERA ADVANCE has shown in vivotro to have improved fascia movement that may obviate the need for costly Wittmann patch placement. Primary Objective: Determine the variable cost savings associated with use of ABTHERA ADVANCE™ without the use of Wittmann patch Hypothesis: The hypothesis is that with use of the ABTHERA ADVANCE will lead to reduced variable costs compared to ABTHERA Open Abdomen dressing with Wittmann patch Secondary Objective(s): Determine the rate of abdominal closure, component separation, and mesh placement with the ABTHERA ADVANCE™ without the use of Wittmann patch Hypothesis: The hypothesis is that rate of abdominal closure, component separation, and mesh placement will appear similar with use of ABTHERA ADVANCE compared to ABTHERA Open Abdomen dressing with Wittmann patch

Conditions

• Necrotizing Pancreatitis

Interventions

Type	Name	Description
DEVICE	Using ABTHERA Advance without a Wittmann Patch	In this group, patients will be receiving only the ABTHERA Advance product, without the use of the Wittmann Patch

Timeline

• Start date: 2020-10-12
• Primary completion: 2022-03-28
• Completion: 2023-03-14
• First posted: 2021-08-03
• Last updated: 2023-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study