Direct Resuscitation of the Open Peritoneum (SH DROP)

Direct Resuscitation of the Open Peritoneum: A Randomized Controlled Trial in Non-Traumatic Patients

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Sanford Medical Center Fargo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Negative Wound Pressure Therapy; Negative Pressure Would Therapy	Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System; Suction set at -125mmHg
Active Comparator: Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation	Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System; Suction set at -125mmHg; Drug: Dianeal PD-2 with 2.5% Dextrose; 800mL to 1000mL of Dianeal PD-2 into Abthera™ and dwell for 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Complications	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)	Through study completion, an average of 6 months
Number of operations and time to closure	how many procedures/how long did it take to close the abdomen	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU Stay	How many days was patient in ICU	up to 4 weeks
Time on Vasopressors	How many days was patient on vasopressors	up to 4 weeks

Collaborators and Investigators

• Sponsor: Sanford Health
• Investigators: Principal Investigator: Mentor Ahmeti, MD, Sanford Health

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Wounds and Injuries; Surgical Wound; Abdomen, Acute; Abdominal Injuries
• Other Study ID Numbers: SH Ahmeti DROP Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: Yes