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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by Saint Elizabeth Regional Medical Center
Sponsor:
Information provided by:
Saint Elizabeth Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01274650
First received: January 4, 2011
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Decubitis Ulcer
Procedure: Indirect Calorimetry

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Correlation Between Wound Volume and Depth of Decubitus Ulcers And Resting Energy Expenditure

Resource links provided by NLM:


Further study details as provided by Saint Elizabeth Regional Medical Center:

Primary Outcome Measures:
  • Does the volume of decubitus ulcers have an effect on a patient's resting energy expenditure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 25
Study Start Date: September 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Decubitis Ulcer
Patients admitted to the hospital with decubitus ulcers in the ischial, sacral, or coccyx area.
Procedure: Indirect Calorimetry
Indirect Calorimetry
Other Name: Patients admitted to the hospital with decubitus ulcers in the ischial, sacral, or coccyx area

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274650

Contacts
Contact: Kathy Holland, RD 402-219-7343 kholland@stez.org

Locations
United States, Nebraska
Saint Elizabeth Regional Burn and Wound Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Kathy Holland, RD    402-219-8732    kholland@stez.org   
Principal Investigator: Kathy Holland, RD         
Sponsors and Collaborators
Saint Elizabeth Regional Medical Center
  More Information

No publications provided

Responsible Party: Kathleen Holland, Saint Elizabeth Regional Medical Center
ClinicalTrials.gov Identifier: NCT01274650     History of Changes
Other Study ID Numbers: 609-040
Study First Received: January 4, 2011
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014