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

Decubitis Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274650
• Other study ID #: 609-040
• Status: Completed
• Phase: N/A
• First received: January 4, 2011
• Last updated: October 12, 2016
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: October 2016
• Source: Saint Elizabeth Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Decubitis Ulcer
• Pressure Ulcer
• Ulcer

Intervention

Procedure:
• Indirect Calorimetry
Indirect Calorimetry

Locations

Country	Name	City	State
United States	Saint Elizabeth Regional Burn and Wound Center	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Paul Edwards

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year	No