ABTHERA ADVANCE™ Use Without Wittman Patch

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04986943

Enrollment

Registered

2021-08-03

Start date

2020-10-12

Completion date

2023-03-14

Last updated

2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Pancreatitis

Keywords

Abdominal compartment syndrome, Necrotizing Pancreatitis, Severe sepsis, Necrotizing Pancreatitis with abdominal compartment syndrome, Necrotizing Pancreatitis with severe sepsis

Brief 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

Interventions

DEVICEUsing 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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Cost Saving	3 months after the last participant has been enrolled.	Determine the variable cost savings associated with use of ABTHERA ADVANCE™ without the use of Wittmann patch.

Secondary

Measure	Time frame	Description
Effectiveness	3 months after the last participant has been enrolled.	Determine the rate of abdominal closure, component separation, and mesh placement with the ABTHERA ADVANCE™ without the use of Wittmann patch.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026