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Direct Resuscitation of the Open Peritoneum

NCT04887480 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-01-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sanford Health

    lead OTHER

Principal Investigators

  • Mentor Ahmeti, MD · Sanford Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-14
Primary Completion
2025-05-30
Completion
2026-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04887480 on ClinicalTrials.gov