ABTHERA ADVANCE™ Use Without Wittman Patch

Wake Forest University Health Sciences3 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Necrotizing Pancreatitis

Interventions

Using ABTHERA Advance without a Wittmann PatchDEVICE

In this group, patients will be receiving only the ABTHERA Advance product, without the use of the Wittmann Patch

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Locations (1)

Atrium Health

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Cost Saving

Determine the variable cost savings associated with use of ABTHERA ADVANCE™ without the use of Wittmann patch.

Time frame: 3 months after the last participant has been enrolled.

Secondary Outcomes

Effectiveness

Determine the rate of abdominal closure, component separation, and mesh placement with the ABTHERA ADVANCE™ without the use of Wittmann patch.

Time frame: 3 months after the last participant has been enrolled.

Data from ClinicalTrials.gov

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