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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.
The use of HTS after DCL may decrease the rate of failure to achieve PFC and reduce the number of complications associated with an open abdomen.
Research Questions:
DCL is a common procedure wounded warriors undergo due to blast and other blunt and penetrating mechanisms of injury. This results in a significant population of warriors at risk for all of the complications and comorbidities that accompany an open abdomen. Thus, finding ways to not only achieve PFC but also to decrease the time to PFC will reduce these unwanted events.
The protocol design is a multi-institutional, prospective, double blind, randomized controlled trial of patients who undergo DCL for abdominal trauma requiring temporary abdominal closure and return to operating room for definitive treatment. All participating facilities are Level I Trauma Centers. Currently, the standard of care for damage control resuscitation involves all intravenous fluid solutions utilized in this study; normal saline, Ringer's lactate, Plasmalyte, and 3% saline (HTS). However, the type of fluid is selected based on surgeon preference alone. Investigators will randomize patients to normal saline at a resuscitation rate of 30 cc/hr or to 3% saline (HTS) at a resuscitation rate of 30cc/hr which will be initiated upon arrival to the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crystalloid resuscitation | Active Comparator | Patients to receive normal saline resuscitation at a rate of 30cc/hr. |
|
| Hypertonic saline resuscitation | Active Comparator | Patients to receive 3% hypertonic saline resuscitation at a rate of 30cc/hr. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Fascial Closure | Procedure | Abdominal wall closure following damage control laparotomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who achieve primary fascial closure | Is there a higher rate of PFC among patients who undergo DCL and temporary abdominal closure when using HTS versus standard crystalloid resuscitation? | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| number of ICU free days | Does successful and faster PFC reduce ICU days? | 30 days |
| number of enterocutaneous fistula | Does faster and more successful PFC result in reduction enterocutaneous fistula (ECF)? |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio Military Medical Center | Recruiting | San Antonio | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23354234 | Background | Harvin JA, Mims MM, Duchesne JC, Cox CS Jr, Wade CE, Holcomb JB, Cotton BA. Chasing 100%: the use of hypertonic saline to improve early, primary fascial closure after damage control laparotomy. J Trauma Acute Care Surg. 2013 Feb;74(2):426-30; discussion 431-2. doi: 10.1097/TA.0b013e31827e2a96. |
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| wound vac dressing application | Device | temporary abdominal wall closure with this device after damage control laparotomy |
|
|
| 90 days |
| number of intra abdominal abscess | Does faster and more successful PFC result in reduction of intra-abdominal abscess (IAA)? | 90 days |
| number of abdominal wall hernias | Does faster and more successful PFC result in reduction in abdominal wall hernia? | 90 days |
| number of anastomotic failure | Does faster and more successful PFC result in a reduction in anastomotic failure? | 90 days |
| number of ventilator free days | Does successful and faster PFC reduce ventilator days? | 30 days |
| number of hospital free days | Does successful and faster PFC reduce hospital days? | 30 days |