Nutritional Support in Pressure Ulcer Patients (OEST)
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Enriched nutrition formula
Control formula
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcers focused on measuring Pressure ulcers, Healing, Malnutrition, Nutritional support, Micronutrients
Eligibility Criteria
Inclusion Criteria:
- patient or legal guardian or caregiver consent
- stage II, III or IV pressure ulcers
- malnutrition (as defined by low body mass index and/or unintentional weight loss and/or low serum albumin and/or reduced food intake [<60% of total daily estimated requirements])
- patients who can drink supplements
- home-care or long-term care
Exclusion Criteria:
- decompensated diabetes (HbA1C >7%)
- renal failure
- hepatic failure (Child B and C)
- current neoplastic disease
- any organ-failure
- immunosuppressive therapy
- connective tissue disease
- use of steroids
- obesity
- respiratory insufficiency (COPD)
- anemia (haemoglobin <10g/dL)
- previous neoplastic disease (<1 year since last treatment CT or RT)
- infected wounds
- cellulitis, sepsis or osteomyelitis
- poor tolerance to sip feeding
Sites / Locations
- Azienda Ospedaliero Universitaria Maggiore della Carita
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Isonitrogenous isocaloric formula
Enriched nutrition formula
Arm Description
Patients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Patients were given standard diet plus 2 bottles of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Outcomes
Primary Outcome Measures
Rate of Healing
healing is defined as reduction in ulcer area (the percentage of change)
Secondary Outcome Measures
Rate of Healing
reduction in ulcer area >=40%
Rate of Healing
complete healing
Incidence of Infections
defined as local (ulcer)
Cost-effectiveness
Incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference between total costs (active - control) by the difference in the mean reduction (%) of ulcer area. Costs are derived from oral nutritional supplements, dressings, antibiotics, PU swab sampling, nurse visits for wound dressing (according to their duration and cost per hour), medical consultations (unitary cost of the visit for prescription of antibiotic therapy).
Dressings
The number of dressings used throughout the intervention period
the Percentage of Change in Area
the reduction in ulcer area (%) observed at 4 weeks
Full Information
NCT ID
NCT01107197
First Posted
April 15, 2010
Last Updated
January 16, 2014
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Collaborators
Nutricia, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01107197
Brief Title
Nutritional Support in Pressure Ulcer Patients
Acronym
OEST
Official Title
Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Collaborators
Nutricia, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pressure ulcers are frequently associated with malnutrition. Previous studies have reported that nutritional support can improve the healing rate of pressure ulcers but no attention has been clearly given to the nutritional status of the patient treated. Moreover, other investigators have suggested the additional healing power of some nutrients. Unfortunately, previous results have been unpowered by small sample size, poor monitoring of compliance to treatments and the confounding effect of other nutrients. The investigators aimed to test the effect and additional benefits of several micronutrients delivered through oral nutritional support on the healing rate of pressure ulcers in malnourished patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
Pressure ulcers, Healing, Malnutrition, Nutritional support, Micronutrients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isonitrogenous isocaloric formula
Arm Type
Active Comparator
Arm Description
Patients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Arm Title
Enriched nutrition formula
Arm Type
Experimental
Arm Description
Patients were given standard diet plus 2 bottles of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Intervention Type
Dietary Supplement
Intervention Name(s)
Enriched nutrition formula
Other Intervention Name(s)
Cubitan (NUTRICIA Italia)
Intervention Description
oral formula enriched in arginine, zinc and antioxidant oligoelements
Intervention Type
Dietary Supplement
Intervention Name(s)
Control formula
Intervention Description
Isonitrogenous isocaloric oral formula
Primary Outcome Measure Information:
Title
Rate of Healing
Description
healing is defined as reduction in ulcer area (the percentage of change)
Time Frame
8 weeks of nutritional support (baseline and week 8)
Secondary Outcome Measure Information:
Title
Rate of Healing
Description
reduction in ulcer area >=40%
Time Frame
8 weeks of nutritional support (baseline and week 8)
Title
Rate of Healing
Description
complete healing
Time Frame
8 weeks of nutritional support (baseline and week 8)
Title
Incidence of Infections
Description
defined as local (ulcer)
Time Frame
8 weeks of nutritional support (baseline and week 8)
Title
Cost-effectiveness
Description
Incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference between total costs (active - control) by the difference in the mean reduction (%) of ulcer area. Costs are derived from oral nutritional supplements, dressings, antibiotics, PU swab sampling, nurse visits for wound dressing (according to their duration and cost per hour), medical consultations (unitary cost of the visit for prescription of antibiotic therapy).
Time Frame
8 weeks of nutritional support (baseline and week 8)
Title
Dressings
Description
The number of dressings used throughout the intervention period
Time Frame
8 weeks of nutritional support (baseline and week 8)
Title
the Percentage of Change in Area
Description
the reduction in ulcer area (%) observed at 4 weeks
Time Frame
4 weeks of nutritional support (baseline and week 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient or legal guardian or caregiver consent
stage II, III or IV pressure ulcers
malnutrition (as defined by low body mass index and/or unintentional weight loss and/or low serum albumin and/or reduced food intake [<60% of total daily estimated requirements])
patients who can drink supplements
home-care or long-term care
Exclusion Criteria:
decompensated diabetes (HbA1C >7%)
renal failure
hepatic failure (Child B and C)
current neoplastic disease
any organ-failure
immunosuppressive therapy
connective tissue disease
use of steroids
obesity
respiratory insufficiency (COPD)
anemia (haemoglobin <10g/dL)
previous neoplastic disease (<1 year since last treatment CT or RT)
infected wounds
cellulitis, sepsis or osteomyelitis
poor tolerance to sip feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico D'Andrea, MD
Organizational Affiliation
Azienda Ospedaliero Universitaria Maggiore della Carita
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Maggiore della Carita
City
Novara
ZIP/Postal Code
28100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
19563522
Citation
Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-specific, versus standard, nutritional support for the treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1395-402. doi: 10.1111/j.1532-5415.2009.02351.x. Epub 2009 Jun 25.
Results Reference
background
PubMed Identifier
11431045
Citation
Benati G, Delvecchio S, Cilla D, Pedone V. Impact on pressure ulcer healing of an arginine-enriched nutritional solution in patients with severe cognitive impairment. Arch Gerontol Geriatr Suppl. 2001;7:43-7. doi: 10.1016/s0167-4943(01)00120-0. No abstract available.
Results Reference
background
PubMed Identifier
15469215
Citation
Frias Soriano L, Lage Vazquez MA, Maristany CP, Xandri Graupera JM, Wouters-Wesseling W, Wagenaar L. The effectiveness of oral nutritional supplementation in the healing of pressure ulcers. J Wound Care. 2004 Sep;13(8):319-22. doi: 10.12968/jowc.2004.13.8.26654.
Results Reference
background
PubMed Identifier
18978686
Citation
Heyman H, Van De Looverbosch DE, Meijer EP, Schols JM. Benefits of an oral nutritional supplement on pressure ulcer healing in long-term care residents. J Wound Care. 2008 Nov;17(11):476-8, 480. doi: 10.12968/jowc.2008.17.11.31475.
Results Reference
background
PubMed Identifier
20598855
Citation
van Anholt RD, Sobotka L, Meijer EP, Heyman H, Groen HW, Topinkova E, van Leen M, Schols JM. Specific nutritional support accelerates pressure ulcer healing and reduces wound care intensity in non-malnourished patients. Nutrition. 2010 Sep;26(9):867-72. doi: 10.1016/j.nut.2010.05.009. Epub 2010 Jul 3.
Results Reference
background
PubMed Identifier
25643304
Citation
Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696. Erratum In: Ann Intern Med. 2015 Dec 15;163(12):964.
Results Reference
derived
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Nutritional Support in Pressure Ulcer Patients
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