Direct Resuscitation of the Open Peritoneum

Abdomen, Acute Clinical Trial

— SH DROP  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04887480
• Other study ID #: SH Ahmeti DROP Study
• Status: Suspended
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: May 30, 2026

Study information

• Verified date: January 2024
• Source: Sanford Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Abdomen, Acute
• Abdominal Injuries
• Surgical Wound
• Wound Surgical
• Wound; Abdomen
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Sanford Medical Center Fargo	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of operations and time to closure	how many procedures/how long did it take to close the abdomen	up to 4 weeks
Secondary	Length of ICU Stay	How many days was patient in ICU	up to 4 weeks
Secondary	Time on Vasopressors	How many days was patient on vasopressors	up to 4 weeks