ABTHERA ADVANCE™ Use Without Wittman Patch

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Necrotizing Pancreatitis

Intervention / Treatment
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* Device: Using ABTHERA Advance without a Wittmann Patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ABTHERA Advance without Wittmann patch<br>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. | Device: Using ABTHERA Advance without a Wittmann Patch<br>* In this group, patients will be receiving only the ABTHERA Advance product, without the use of the Wittmann Patch<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal compartment syndrome, Necrotizing Pancreatitis, Severe sepsis, Necrotizing Pancreatitis with abdominal compartment syndrome, Necrotizing Pancreatitis with severe sepsis