Direct Resuscitation of the Open Peritoneum

Sanford Health200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Wound; Abdomen Abdomen, Acute Wound Surgical

Interventions

Abthera™ Open Abdomen Negative Pressure Therapy Device SystemDEVICE

Suction set at -125mmHg

Dianeal PD-2 with 2.5% DextroseDRUG

800mL to 1000mL of Dianeal PD-2 into Abthera™ and dwell for 1 hour.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Sanford Medical Center Fargo

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: up to 4 weeks

Secondary Outcomes

Length of ICU Stay

How many days was patient in ICU

Time frame: up to 4 weeks

Time on Vasopressors

How many days was patient on vasopressors

Time frame: up to 4 weeks

Data from ClinicalTrials.gov

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