Nutritional Support in Pressure Ulcer Patients

Pressure Ulcers Clinical Trial

— OEST  

Official title:

Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107197
• Other study ID #: 473/CE (Study n° CE 61/07)
• Status: Completed
• Phase: N/A
• First received: April 15, 2010
• Last updated: January 16, 2014
• Start date: February 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Dietary Supplement:
• Enriched nutrition formula
oral formula enriched in arginine, zinc and antioxidant oligoelements
• Control formula
Isonitrogenous isocaloric oral formula

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Maggiore della Carita	Novara

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita	NUTRICIA Italia

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View Citation

Frías Soriano L, Lage Vázquez 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. — View 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. — View Citation

van Anholt RD, Sobotka L, Meijer EP, Heyman H, Groen HW, Topinková 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Healing	healing is defined as reduction in ulcer area (the percentage of change)	8 weeks of nutritional support (baseline and week 8)	No
Secondary	Rate of Healing	reduction in ulcer area >=40%	8 weeks of nutritional support (baseline and week 8)	No
Secondary	Rate of Healing	complete healing	8 weeks of nutritional support (baseline and week 8)	No
Secondary	Incidence of Infections	defined as local (ulcer)	8 weeks of nutritional support (baseline and week 8)	No
Secondary	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).	8 weeks of nutritional support (baseline and week 8)	No
Secondary	Dressings	The number of dressings used throughout the intervention period	8 weeks of nutritional support (baseline and week 8)	No
Secondary	the Percentage of Change in Area	the reduction in ulcer area (%) observed at 4 weeks	4 weeks of nutritional support (baseline and week 4)	No