Abdomen, Acute, Wound; Abdomen, Wound Surgical
Conditions
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
Interventions
DEVICEAbthera™ Open Abdomen Negative Pressure Therapy Device System
Suction set at -125mmHg
DRUGDianeal PD-2 with 2.5% Dextrose
800mL to 1000mL of Dianeal PD-2 into Abthera™ and dwell for 1 hour.
Sponsors
Sanford Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Complications | Through study completion, an average of 6 months | 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) |
| Number of operations and time to closure | up to 4 weeks | how many procedures/how long did it take to close the abdomen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU Stay | up to 4 weeks | How many days was patient in ICU |
| Time on Vasopressors | up to 4 weeks | How many days was patient on vasopressors |
Countries
United States
Outcome results
None listed