Enteral Feeding in the Post-Injury Open Abdomen

Trauma to the Abdomen Clinical Trial

Official title:

Enteral Nutrition in the Open Abdomen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853735
• Other study ID #: 13-0077
• Status: Completed
• Start date: January 2013
• Est. completion date: June 29, 2022

Study information

• Verified date: September 2022
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: June 29, 2022
• Est. primary completion date: June 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 98 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Injuries
• Trauma to the Abdomen

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	infectious complications	physical exam and imaging will be reviewed to assess infections	participants will be followed for their hospital stay, which is on average expected to be 1 month
Primary	fascial closure rate	physical exam will document fascial closure	participants will be followed for their hospital stay, which is on average expected to be 1 month
Secondary	mortality	subject mortality status	participants will be followed for their hospital stay, which is on average expected to be 1 month