NCT04887480

Direct Resuscitation of the Open Peritoneum

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sanford Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Wound; Abdomen
• Abdomen, Acute
• Wound Surgical

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-14
• Primary completion: 2025-05-30
• Completion: 2026-05-30
• First posted: 2021-05-14
• Last updated: 2024-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study