Recruiting

Hypertonic Saline

Sponsor:

San Antonio Military Medical Center

Code:

NCT02297659

Conditions

Open Abdomen After Damage Control Laparotomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Primary Fascial Closure

wound vac dressing application

Study Details

Brief summary:

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.

Conditions

Open Abdomen After Damage Control Laparotomy

Study ID

NCT02297659

Start date

Aug, 2014

Status verified date

Dec, 2015

Completion date

Jan, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

312 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Crystalloid resuscitation

Patients to receive normal saline resuscitation at a rate of 30cc/hr.

active comparator: Hypertonic saline resuscitation

Patients to receive 3% hypertonic saline resuscitation at a rate of 30cc/hr.

Interventions

Primary Fascial Closure

Abdominal wall closure following damage control laparotomy.

wound vac dressing application

temporary abdominal wall closure with this device after damage control laparotomy

Primary outcome measure

  • Number of participants who achieve primary fascial closure [ Time Frame: 2 weeks ]

Central Contacts and Locations

Locations

San Antonio Military Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Valerie G Sams, MD

859-230-0417valerie.g.sams.mil@mail.mil

Michelle F Buehner, MD

michelle.f.buehner.mil@mail.mil

Principal Investigator:

Valerie G Sams, MD

More Information

Sponsor

San Antonio Military Medical Center

Last update posted

Dec 15, 2015

Last verified

Dec, 2015

Keywords

  • damage control
  • resuscitation
  • laparotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by San Antonio Military Medical Center on 2015-12-15.