Direct Resuscitation of the Open Peritoneum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2026-05-30

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

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Detailed Description

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Conditions

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Wound; Abdomen Abdomen, Acute Wound Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Negative Wound Pressure Therapy

Negative Pressure Would Therapy

Group Type ACTIVE_COMPARATOR

Abthera™ Open Abdomen Negative Pressure Therapy Device System

Intervention Type DEVICE

Suction set at -125mmHg

Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation

Group Type ACTIVE_COMPARATOR

Abthera™ Open Abdomen Negative Pressure Therapy Device System

Intervention Type DEVICE

Suction set at -125mmHg

Dianeal PD-2 with 2.5% Dextrose

Intervention Type DRUG

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

Interventions

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Abthera™ Open Abdomen Negative Pressure Therapy Device System

Suction set at -125mmHg

Intervention Type DEVICE

Dianeal PD-2 with 2.5% Dextrose

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

Intervention Type DRUG

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No