ABTHERA ADVANCE™ Use Without Wittman Patch

Completed

• Conditions: Necrotizing Pancreatitis
• Interventions: Device: Using ABTHERA Advance without a Wittmann Patch

• Registration Number: NCT04986943
• Lead Sponsor: Wake Forest University Health Sciences

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

Study Timeline

• Study Start: 2020-10-12
• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-03
• Primary Completion: 2022-03-28
• Study Completion: 2023-03-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ABTHERA Advance without Wittmann patch	Using ABTHERA Advance without a Wittmann Patch	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States