Clinical trial NCT01107197: Nutritional Support in Pressure Ulcer Patients
Official title: Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcers
Keywords: Pressure ulcers
Healing
Malnutrition
Nutritional support
Micronutrients
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
Collaborators: name: Nutricia, Inc.
First posted: 2010-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of Healing
timeFrame: 8 weeks of nutritional support (baseline and week 8)
Secondary outcomes:
measure: Rate of Healing
timeFrame: 8 weeks of nutritional support (baseline and week 8)
measure: Rate of Healing
timeFrame: 8 weeks of nutritional support (baseline and week 8)
measure: Incidence of Infections
timeFrame: 8 weeks of nutritional support (baseline and week 8)
measure: Cost-effectiveness
timeFrame: 8 weeks of nutritional support (baseline and week 8)
measure: Dressings
timeFrame: 8 weeks of nutritional support (baseline and week 8)
measure: the Percentage of Change in Area
timeFrame: 4 weeks of nutritional support (baseline and week 4)
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carita
Study officials:
affiliation: Azienda Ospedaliero Universitaria Maggiore della Carita
name: Federico D'Andrea, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.