Use of Hypertonic Saline After Damage Control Laparotomy to Improve Early Primary Fascial Closure
Status unconfirmed · Not applicable
Conditions studied: Open Abdomen After Damage Control Laparotomy
In brief
Damage control laparotomy (DCL) has proven to be a successful means to improve survival in severely injured patients.1-5 However, the consequences of not being able to close the fascia after the initial operation due to significant resuscitation leading to bowel and retroperitoneal edema, abdominal compartment syndrome, and continued acidosis, coagulopathy and hypethermia6-7 has led to a new challenge. Delays in primary fascial closure (PFC) contributes to increased fluid losses and nutritional demands,8-9 abdominal wall hernias, enterocutaneous fistula, and intra-abdominal infections.10-13 Hypertonic saline (HTS) use after DCL has been suggested to reduce bowel edema and resuscitation volumes, thus allowing for a quicker time to closure.14 Investigators will randomize patients to receiving HTS or standard crystalloid solutions after DCL and compare the time to PFC, rate of successful closure, and rate of complications associated with an open abdomen. The current failure rate of PFC after DCL is approximately 25%. Investigators believe they can improve PFC rates using hypertonic saline.
Key facts
- Study ID
- NCT02297659
- Run by
- San Antonio Military Medical Center
- People needed
- 312
- Starts
- 2014-08-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2015-12-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All admissions of trauma patients who sustain trauma necessitating damage control laparotomy.
- Male and female patients 18 years or older.
You may not qualify if…
- Children (<18 years old), prisoners, or pregnant patients.
- Patients who have more than 1/3 loss of abdominal wall due to trauma.
- Patients with baseline serum sodium of <120 mEq/L or >155 mEq/L.
Where it is running
- San Antonio Military Medical Center — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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