NCT02297659

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

2.3 years

First QC Date

August 1, 2014

Last Update Submit

December 13, 2015

Conditions

Open Abdomen After Damage Control Laparotomy

Keywords

damage controlresuscitationlaparotomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • number of ICU free days

    30 days

  • number of enterocutaneous fistula

    90 days

  • number of intra abdominal abscess

    90 days

  • number of abdominal wall hernias

    90 days

  • number of anastomotic failure

    90 days

  • +2 more secondary outcomes

Study Arms (2)

Crystalloid resuscitation

ACTIVE COMPARATOR

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

Procedure: Primary Fascial ClosureDevice: wound vac dressing application

Hypertonic saline resuscitation

ACTIVE COMPARATOR

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

Procedure: Primary Fascial ClosureDevice: wound vac dressing application

Interventions

Primary Fascial ClosurePROCEDURE

Abdominal wall closure following damage control laparotomy.

Crystalloid resuscitationHypertonic saline resuscitation
wound vac dressing applicationDEVICE

temporary abdominal wall closure with this device after damage control laparotomy

Also known as: AbThera woulnd vac (KCI)
Crystalloid resuscitationHypertonic saline resuscitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23354234BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Acute Care Surgery Fellow

Study Record Dates

First Submitted

August 1, 2014

First Posted

November 21, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

US(1)