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Enteral Feeding in the Post-Injury Open Abdomen

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ClinicalTrials.gov Identifier: NCT01853735
Recruitment Status : Recruiting
First Posted : May 15, 2013
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
C. Clay Cothren, MD, Denver Health and Hospital Authority

Brief Summary:

The purpose of this study is to determine if Enteral Feeding (EN) in patients with a traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN will be compared to those who remain nil-per-os (NPO). Additionally, an internal study control will be performed by analyzing concurrent injured patients requiring an open abdomen who did not have a bowel injury.

Specific aims:

Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves fascial closure rate compared to patients who remain NPO.

Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces infectious complications compared to patients who remain NPO.

Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a lower mortality rate compared to patients who remain NPO.


Condition or disease
Trauma to the Abdomen

Detailed Description:
Fascial closure is determine by the primary physician and should be recorded in the operative record. This record will be accessed to determine if this variable is accomplished. Additionally, any dehiscence complication will be recorded (which would impact the long-term fascial closure rate). Infectious complications (abscess, pneumonia, etc) will be adjudicated by the primary clinician and any record of this in the patient chart will be recorded.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enteral Nutrition in the Open Abdomen
Study Start Date : January 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Group/Cohort
bowel injury, NPO
Patients with bowel injury who remain nil-per-os (fed nothing)
bowel injury, EN
Patients with bowel injury who are fed by enteral nutrition (EN)
no bowel injury, NPO
Patients without bowl injury who remain nil-per-os (fed nothing)
no bowel injury, EN
Patient without bowl injury who are fed by enteral nutrition (EN)



Primary Outcome Measures :
  1. fascial closure rate [ Time Frame: participants will be followed for their hospital stay, which is on average expected to be 1 month ]
    physical exam will document fascial closure


Secondary Outcome Measures :
  1. mortality [ Time Frame: participants will be followed for their hospital stay, which is on average expected to be 1 month ]
    subject mortality status


Other Outcome Measures:
  1. infectious complications [ Time Frame: participants will be followed for their hospital stay, which is on average expected to be 1 month ]
    physical exam and imaging will be reviewed to assess infections



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Ages Eligible for Study:   18 Years to 98 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients requiring an open abdomen following trauma will be prospectively followed.
Criteria

Inclusion Criteria:

  • All patients with a post-injury open abdomen

Exclusion Criteria:

  • Patients to be excluded from analysis include deaths within 24 hours, identification of injury > 24 hours, and those transferred from an outside hospital > 24 hours following initial injury.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853735


Contacts
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Contact: Clay Cothren, MD 303-436-6558 clay.cothren@dhha.org

Locations
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United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Principal Investigator: Clay Cothren Burlew, MD         
Sponsors and Collaborators
Denver Health and Hospital Authority
Investigators
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Principal Investigator: Clay Cothren Burlew, MD Denver Health and Hospital Authority
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Responsible Party: C. Clay Cothren, MD, Director, Surgical Intensive Care Unit, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01853735    
Other Study ID Numbers: 13-0077
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Abdominal Injuries
Wounds and Injuries