- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01274650
Correlation Between Wound Volume and Depth of Decubitus Ulcers And Resting Energy Expenditure
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Saint Elizabeth Regional Burn and Wound Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Decubitis Ulcer
Patients admitted to the hospital with decubitus ulcers in the ischial, sacral, or coccyx area.
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Indirect Calorimetry
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Does the volume of decubitus ulcers have an effect on a patient's resting energy expenditure
Time Frame: 1 year
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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
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1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 609-040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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