Direct Resuscitation of the Open Peritoneum

Study Overview
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Brief Summary
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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

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

Conditions
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Wound; Abdomen, Abdomen, Acute, Wound Surgical

Intervention / Treatment
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* Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System
* Drug: Dianeal PD-2 with 2.5% Dextrose


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |