ABTHERA ADVANCE™ Use Without Wittman Patch

NCT04986943 | Completed FDA Device

• 2 other identifiers: IRB0008273408-20-01A
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Pancreatitis

Keywords

Abdominal compartment syndrome; Necrotizing Pancreatitis; Severe sepsis; Necrotizing Pancreatitis with abdominal compartment syndrome; Necrotizing Pancreatitis with severe sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness

  3 months after the last participant has been enrolled.

Study Arms (1)

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

Interventions

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

ABTHERA Advance without Wittmann patch

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Female patients who are pregnant or lactating
• If in the opinion of the treating physician a patient should not participate in this study.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• 3M: collaborator

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Related Publications (14)

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MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Intra-Abdominal Hypertension; Sepsis

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dionisios Vrochides, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: October 12, 2020
• Primary Completion: March 28, 2022
• Study Completion: March 14, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

US (1)