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Correlation Between Wound Volume and Depth of Decubitus Ulcers And Resting Energy Expenditure

Primary Purpose

Decubitis Ulcer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indirect Calorimetry
Sponsored by
Paul Edwards
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decubitis Ulcer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admitted to the Saint Elizabeth Regional Burn and Wound Center
  • Ulcer located in the Ischial, Sacral, Coccyx

Exclusion Criteria:

  • Patient Has Signs of Infection
  • Patient is receiving oxandrolone treatment or anabolic hormone treatment
  • Is Patients receiving intermittent tube feedings

Sites / Locations

  • Saint Elizabeth Regional Burn and Wound Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Decubitis Ulcer

Arm Description

Patients admitted to the hospital with decubitus ulcers in the ischial, sacral, or coccyx area.

Outcomes

Primary Outcome Measures

Does the volume of decubitus ulcers have an effect on a patient's resting energy expenditure
Data obtained in this study will be analyzed using methods that enable a description of the patient population and a comparison of the results against previously formulated equations for energy expenditure. Descriptive summaries will be presented for demographic and clinical background variables, study objectives, and outcome variables and safety endpoint

Secondary Outcome Measures

Full Information

First Posted
January 4, 2011
Last Updated
October 12, 2016
Sponsor
Paul Edwards
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1. Study Identification

Unique Protocol Identification Number
NCT01274650
Brief Title
Correlation Between Wound Volume and Depth of Decubitus Ulcers And Resting Energy Expenditure
Official Title
Correlation Between Wound Volume and Depth of Decubitus Ulcers And Resting Energy Expenditure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul Edwards

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patient nutritional needs vary depending on several factors including age, sex, height, weight, injury and co-morbidities. Since injury affects energy expenditure in patients, this must be taken into account when assessing nutritional requirements. Indirect calorimetry will be used to measure energy expenditure of patients with decubitus ulcers of varying degrees. The primary objective of this study is to determine the effects of wound volume on metabolic rate and compare this to predictive equations used for estimating energy requirements.
Detailed Description
Adequate nutrition is an important aspect of wound healing because it provides an anabolic environment necessary for tissue repair. Without proper nutrition support, healing can be prolonged and even inhibited. Provision of adequate energy is essential in patients with decubitus ulcers to maximize nitrogen retention and facilitate wound healing. (1,2) There are few published studies that measure energy needs in patients with decubitus ulcers. Spinal cord injured patients are one of the few populations where studies have utilized indirect calorimetry to measure energy expenditure. Individuals with spinal cord injuries are particularly at risk for developing pressure ulcers. Liu, et al. (3) measured energy expenditure in 16 individuals with quadriplegia and pressure ulcers and in 16 individuals with quadriplegia but no pressure ulcers. Measured energy expenditure was significantly higher in subjects with quadriplegia and pressure ulcers. Additionally, pressure ulcer surface area was significantly correlated with predicted resting energy expenditure. In a study of paraplegic individuals, Alexander, et al. (4) found resting metabolic rate was significantly higher in those individuals with pressure ulcers compared to those with paraplegia without pressure ulcers. Additional research is needed to confirm these findings. To determine nutrition requirements specific to each patient, energy needs must be estimated, taking into account weight, height, age, activity level as well as the size of the wound and the patient's co-morbidities. Although indirect calorimetry is the gold standard for measuring metabolic rate, it is impractical and time consuming to use this method to determine needs of every patient. Therefore, the clinician uses predictive formulas for estimating energy needs. The most commonly cited guideline for energy requirements for healing pressure ulcers is 30-35 kcal/kg (recommendation, National Pressure Ulcer Advisory Panel).(1) The European Pressure Ulcer Advisory Panel has also recommended a minimum of 30-35 kcal/kg.(2) Several equations have been derived to predict metabolic rate based on age, height, weight, and sex. Two of these predictive equations are the Harris Benedict (5) and the Mifflin-St. Jeor. (6) These equations can be adjusted for injury factors, but it is unclear if they fully account for the size of wound in patients with decubiti.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decubitis Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decubitis Ulcer
Arm Type
Other
Arm Description
Patients admitted to the hospital with decubitus ulcers in the ischial, sacral, or coccyx area.
Intervention Type
Procedure
Intervention Name(s)
Indirect Calorimetry
Other Intervention Name(s)
Patients admitted to the hospital with decubitus ulcers in the ischial, sacral, or coccyx area
Intervention Description
Indirect Calorimetry
Primary Outcome Measure Information:
Title
Does the volume of decubitus ulcers have an effect on a patient's resting energy expenditure
Description
Data obtained in this study will be analyzed using methods that enable a description of the patient population and a comparison of the results against previously formulated equations for energy expenditure. Descriptive summaries will be presented for demographic and clinical background variables, study objectives, and outcome variables and safety endpoint
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admitted to the Saint Elizabeth Regional Burn and Wound Center Ulcer located in the Ischial, Sacral, Coccyx Exclusion Criteria: Patient Has Signs of Infection Patient is receiving oxandrolone treatment or anabolic hormone treatment Is Patients receiving intermittent tube feedings
Facility Information:
Facility Name
Saint Elizabeth Regional Burn and Wound Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States

12. IPD Sharing Statement

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Correlation Between Wound Volume and Depth of Decubitus Ulcers And Resting Energy Expenditure

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