Use of Hypertonic Saline After Damage Control Laparotomy to Improve Early Primary Fascial Closure

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.

Study Overview

• Status: Unknown
• Conditions: Open Abdomen After Damage Control Laparotomy
• Intervention / Treatment: Procedure: Primary Fascial Closure; Device: wound vac dressing application

Detailed Description

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:

1. Primary Objective: Is there a higher rate of PFC among patients who undergo DCL and temporary abdominal closure when using HTS versus standard crystalloid resuscitation?
2. Secondary Objectives: Does successful and faster PFC reduce ICU, ventilator and hospital days?
3. Does faster and more successful PFC result in lower morbidity to include enterocutaneous fistula (ECF), intra-abdominal abscess (IAA), abdominal wall hernia, and anastomotic failure?

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.

• Study Type: Interventional
• Enrollment (Anticipated): 312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78234
      • Recruiting
      • San Antonio Military Medical Center
      • Contact: Valerie G Sams, MD; Phone Number: 859-230-0417; Email: valerie.g.sams.mil@mail.mil
      • Contact: Michelle F Buehner, MD; Email: michelle.f.buehner.mil@mail.mil
      • Principal Investigator: Valerie G Sams, MD
      • Sub-Investigator: Michelle F Buehner, MD
      • Sub-Investigator: Christopher E White, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All admissions of trauma patients who sustain trauma necessitating damage control laparotomy.
• Male and female patients 18 years or older.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Crystalloid resuscitation; Patients to receive normal saline resuscitation at a rate of 30cc/hr.	Procedure: Primary Fascial Closure; Abdominal wall closure following damage control laparotomy.; Device: wound vac dressing application; temporary abdominal wall closure with this device after damage control laparotomy; Other Names: AbThera woulnd vac (KCI)
Active Comparator: Hypertonic saline resuscitation; Patients to receive 3% hypertonic saline resuscitation at a rate of 30cc/hr.	Procedure: Primary Fascial Closure; Abdominal wall closure following damage control laparotomy.; Device: wound vac dressing application; temporary abdominal wall closure with this device after damage control laparotomy; Other Names: AbThera woulnd vac (KCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)?	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

Collaborators and Investigators

• Sponsor: San Antonio Military Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: August 1, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 13, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: laparotomy; resuscitation; damage control
• Other Study ID Numbers: 397284-1