Skip to main content
OpenTrials
Completed

NCT Number: NCT04986943

ABTHERA ADVANCE™ Use Without Wittman Patch

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Using ABTHERA Advance without a Wittmann Patch

Device

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

Primary outcomes

  1. Cost Saving

    Time frame: 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 outcomes

  1. Effectiveness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 3, 2021
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.