ABTHERA ADVANCE™ Use Without Wittman Patch

Wake Forest University (WFU)

Status: Completed

Conditions: Necrotizing Pancreatitis

Treatments: Device: Using ABTHERA Advance without a Wittmann Patch

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04986943

IRB00082734

08-20-01A

Details and patient eligibility

About

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.

Full 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

Enrollment: 3 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female patients aged ≥ 22
• Severe necrotizing pancreatitis with abdominal compartment syndrome or severe sepsis requiring decompressive laparotomy and/or pancreatic debridement
• Patients that require open abdomen at the conclusion of their index operation

Exclusion criteria

• Female patients who are pregnant or lactating
• If in the opinion of the treating physician a patient should not participate in this study.

Trial design

3 participants in 1 patient group

ABTHERA Advance without Wittmann patch

Description:

Patients with necrotizing pancreatitis that require an open abdomen after their initial operation will be treated with ABTHERA ADVANCE only, without the use of Wittmann patch.

Treatment:

Device: Using ABTHERA Advance without a Wittmann Patch