ABTHERA ADVANCE™ Use Without Wittman Patch

August 30, 2023 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The target study population is patients with necrotizing pancreatitis that require an open abdomen. Pancreatitis is a wide spectrum of disease, however patients with necrotizing pancreatitis are a relatively small subset. As a quaternary care center for patients with pancreatic diseases, most patients in Atrium's care network with severe necrotizing pancreatitis are referred to Carolinas Medical Center. The patients that will be approached for this study are those in the intensive care unit that develop abdominal compartment syndrome or severe pancreatitis requiring laparotomy. The goal for patient enrollment will be 20 patients and outcomes for these patients will be compared to a historical cohort of 40 patients.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ABTHERA Advance without 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.
Device: Using 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after the last participant has been enrolled.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after the last participant has been enrolled.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

3M

Investigators

  • Principal Investigator: Dionisios Vrochides, MD, PhD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2020

Primary Completion (Actual)

March 28, 2022

Study Completion (Actual)

March 14, 2023

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00082734
  • 08-20-01A (Other Identifier: Atrium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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