Direct Resuscitation of the Open Peritoneum

NCT04887480 | Suspended FDA Device

• 1 other identifier: SH Ahmeti DROP Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Major Complications

  Major complications (yes/no). Major complications include intra-abdominal abscess, wound dehiscence, anastomotic leak, intra-abdominal bleed, biloma, enterocutaneous fistula, evisceration, acute respiratory distress syndrome (ARDS)

  Through study completion, an average of 6 months

• Number of operations and time to closure

  how many procedures/how long did it take to close the abdomen

  up to 4 weeks

Secondary Outcomes (2)

• Length of ICU Stay

  up to 4 weeks

• Time on Vasopressors

  up to 4 weeks

Study Arms (2)

Negative Wound Pressure Therapy

ACTIVE COMPARATOR

Negative Pressure Would Therapy

Device: Abthera™ Open Abdomen Negative Pressure Therapy Device System

Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation

ACTIVE COMPARATOR

Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation

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

Interventions

Abthera™ Open Abdomen Negative Pressure Therapy Device System DEVICE

Suction set at -125mmHg

Negative Wound Pressure Therapy; Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation

Dianeal PD-2 with 2.5% Dextrose DRUG

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

Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sanford Health: lead

Study Sites (1)

Sanford Medical Center Fargo

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Conditions

Abdominal Injuries; Abdomen, Acute; Surgical Wound

Interventions

Glucose

Condition Hierarchy (Ancestors)

Wounds and Injuries; Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Mentor Ahmeti, MD

  Sanford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 14, 2021
• Study Start: May 14, 2021
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)