Use of Hypertonic Saline (a concentrated salt solution) After Abdominal Trauma Surgery to Improve Wound Healing

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"This study will look at using a concentrated salt solution versus standard salt solution in IV's given after abdominal trauma surgery."
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: laporotomy, hypertonic saline, abdominal trauma
Type: Procedure study
Target:
60 Participants
Investigator:
Description
This study will examine using hypertonic saline (a concentrated salt solution). The study team wants to learn if it is better than standard intravenous (given through a vein) salt solutions. It will be used after abdominal trauma.

We are investigating whether using hypertonic saline will improve wound healing. We hope it will also result in less injury to organs in the abdomen and decreased time in the ICU and/or the hospital.
This study requires

When patients involved in accidents or traumas arrive at the hospital, they are evaluated in the ER. The trauma surgeon decides if a patient needs an operation to see if there is abdominal bleeding or injury. After the operation, some patients have a temporary abdominal closure. The plan is to take them back to the operating room for more procedures later. During this time, patients are admitted to the intensive care unit. Their care is managed with intravenous (IV - given through a vein) fluids and other medications. This care continues until the surgeon is able to close the patient’s abdominal wall.

Your participation in this study begins after your exploratory surgery to evaluate the damage in your abdomen. After your surgery, will either receive a standard IV salt solution or a concentrated salt solution.

You will be randomly assigned to one of these two resuscitation plans. Randomization is a process like flipping a coin. Neither you nor the study doctor will know which treatment you are getting. You will not know which group you are in until the end of the study.

Who can participate

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.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will take part in this study throughout your hospitalization related to your abdominal injury. We may also collect follow-up information for no more than 30 days after your operation.
Recruitment period
From Oct. 29, 2015
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Clinical Trials Office
Research Topic
Conditions:
  • Open Abdomen After Damage Control Laparotomy

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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