Direct Resuscitation of the Open Peritoneum (SH DROP)

Sanford Health

Status: Suspended

Conditions: Wound Surgical; Wound; Abdomen; Abdomen, Acute

Treatments: Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System; Drug: Dianeal PD-2 with 2.5% Dextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT04887480

SH Ahmeti DROP Study

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Negative Wound Pressure Therapy

Active Comparator group

Description:

Negative Pressure Would Therapy

Treatment:

Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System

Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation

Active Comparator group

Description:

Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation

Treatment:

Drug: Dianeal PD-2 with 2.5% Dextrose

Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System