Clinical trial NCT04986943: ABTHERA ADVANCE™ Use Without Wittman Patch
Official title: Use of the ABTHERA ADVANCE™ Open Abdomen Dressing in Patients With Necrotizing Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Pancreatitis
Keywords: Abdominal compartment syndrome
Necrotizing Pancreatitis
Severe sepsis
Necrotizing Pancreatitis with abdominal compartment syndrome
Necrotizing Pancreatitis with severe sepsis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2021-08-03
Enrollment: 3
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Cost Saving
timeFrame: 3 months after the last participant has been enrolled.
Secondary outcomes:
measure: Effectiveness
timeFrame: 3 months after the last participant has been enrolled.
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Dionisios Vrochides, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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