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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Wound Pressure Therapy | Active Comparator | Negative Pressure Would Therapy |
|
| Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation | Active Comparator | Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abtheraâ„¢ Open Abdomen Negative Pressure Therapy Device System | Device | Suction set at -125mmHg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU Stay | How many days was patient in ICU | up to 4 weeks |
| Time on Vasopressors | How many days was patient on vasopressors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mentor Ahmeti, MD | Sanford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford Medical Center Fargo | Fargo | North Dakota | 58104 | United States |
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| ID | Term |
|---|---|
| D000007 | Abdominal Injuries |
| D000006 | Abdomen, Acute |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D015746 | Abdominal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| Dianeal PD-2 with 2.5% Dextrose | Drug | 800mL to 1000mL of Dianeal PD-2 into Abtheraâ„¢ and dwell for 1 hour. |
|
| up to 4 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |