SuspendedNot Applicable

Direct Resuscitation of the Open Peritoneum

Stopped: Funding paused

United States200 participantsStarted 2021-05-14

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Major Complications

Timeframe: Through study completion, an average of 6 months

Number of operations and time to closure

Timeframe: up to 4 weeks

Trial details

NCT IDNCT04887480

SponsorSanford Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30