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

NCT02297659 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2015-12-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • San Antonio Military Medical Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02297659 on ClinicalTrials.gov