Direct Resuscitation of the Open Peritoneum

Not Applicable

Suspended

• Conditions: Wound Surgical; Abdomen, Acute; Wound; Abdomen
• Interventions: Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System; Drug: Dianeal PD-2 with 2.5% Dextrose

• Registration Number: NCT04887480
• Lead Sponsor: Sanford Health

Brief Summary

The DROP trial evaluates two ways of treating patients whose abdomens are left open after their abdominal surgery. The current standard of care at Sanford is for patients to have their wound covered with a sterile dressing connected to a vacuum with suction, which removes fluid from the abdomen. In this trial, we are evaluating the benefits of adding dialysis fluid to the abdomen periodically, prior to suctioning it out with the vacuum system. This trial will show if the addition of this fluid lowers the risk of complications and death, and allows the surgeon to close the abdomen sooner

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-10
• Study Start: 2021-05-14
• Study First Posted: 2021-05-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19
• Primary Completion: 2025-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• ≥18 years of age
• Have index operation performed by one of the Trauma and Acute Care surgeons at Sanford Medical Center Fargo
• Require an open abdomen due to a non-traumatic cause and placement of an Abthera™ wound vacuum
• Cognitively impaired adults will be included if a Legally Authorized Representative is available to provide informed consent.

Exclusion Criteria

• Patients under the age of 18
• Vulnerable populations such as pregnant women and prisoners
• Patients with open abdomens as the result of trauma
• Non-English speaking (Due to time constraints pre-operatively and the length of time necessary to secure translation services, non-English speaking patients will not be enrolled).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation	Dianeal PD-2 with 2.5% Dextrose	Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation
Negative Wound Pressure Therapy	Abthera™ Open Abdomen Negative Pressure Therapy Device System	Negative Pressure Would Therapy
Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation	Abthera™ Open Abdomen Negative Pressure Therapy Device System	Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation

Primary Outcome Measures

Name	Time	Method
Major Complications	Through study completion, an average of 6 months	Major complications (yes/no). Major complications include intra-abdominal abscess, wound dehiscence, anastomotic leak, intra-abdominal bleed, biloma, enterocutaneous fistula, evisceration, acute respiratory distress syndrome (ARDS)
Number of operations and time to closure	up to 4 weeks	how many procedures/how long did it take to close the abdomen

Secondary Outcome Measures

Name	Time	Method
Length of ICU Stay	up to 4 weeks	How many days was patient in ICU
Time on Vasopressors	up to 4 weeks	How many days was patient on vasopressors

Trial Locations

Locations (1)

Sanford Medical Center Fargo; 🇺🇸 Fargo, North Dakota, United States