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OpenTrials
Completed

NCT Number: NCT01853735

Enteral Feeding in the Post-Injury Open Abdomen

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.

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Key information

Conditions

Trauma to the Abdomen Abdominal Injuries Wounds and Injuries

Age range

18 year–98 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Registry information

Official study title

Enteral Nutrition in the Open Abdomen

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
May 15, 2013
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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