Nutritional Support in Pressure Ulcer Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01107197

Acronym

OEST

Enrollment

200

Registered

2010-04-20

Start date

2010-02-28

Completion date

2012-11-30

Last updated

2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcers

Keywords

Pressure ulcers, Healing, Malnutrition, Nutritional support, Micronutrients

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.

Interventions

DIETARY_SUPPLEMENTEnriched nutrition formula

oral formula enriched in arginine, zinc and antioxidant oligoelements

DIETARY_SUPPLEMENTControl formula

Isonitrogenous isocaloric oral formula

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of Healing	8 weeks of nutritional support (baseline and week 8)	healing is defined as reduction in ulcer area (the percentage of change)

Secondary

Measure	Time frame	Description
Rate of Healing	8 weeks of nutritional support (baseline and week 8)	reduction in ulcer area \>=40%
Incidence of Infections	8 weeks of nutritional support (baseline and week 8)	defined as local (ulcer)
Cost-effectiveness	8 weeks of nutritional support (baseline and week 8)	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	8 weeks of nutritional support (baseline and week 8)	The number of dressings used throughout the intervention period
the Percentage of Change in Area	4 weeks of nutritional support (baseline and week 4)	the reduction in ulcer area (%) observed at 4 weeks

Countries

Italy

Participant flow

Recruitment details

Participants: patients (long-term care residents or subjects at home care services) with stage 2, 3 or 4 pressure ulcer. Estimated recruitment (sample size): 220 patients. Patients recruited and randomized to interventionas: 200 patients. The recruitment was stopped when at least 64 patients per treatment arm were available for analyses.

Participants by arm

Arm	Count
Enriched Nutrition Formula Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements	78
Isonitrogenous Isocaloric Formula Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one Control formula : Isonitrogenous isocaloric oral formula	79
Total	157

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	12	10
Overall Study	Lost to Follow-up	5	8
Overall Study	Withdrawal by Subject	3	5

Baseline characteristics

Characteristic	Isonitrogenous Isocaloric Formula	Enriched Nutrition Formula	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	75 Participants	73 Participants	148 Participants
Age, Categorical Between 18 and 65 years	4 Participants	5 Participants	9 Participants
Age, Continuous	81.2 years STANDARD_DEVIATION 11.3	80.6 years STANDARD_DEVIATION 11.4	80.9 years STANDARD_DEVIATION 11.3
Region of Enrollment Italy	79 participants	78 participants	157 participants
Sex: Female, Male Female	52 Participants	57 Participants	109 Participants
Sex: Female, Male Male	27 Participants	21 Participants	48 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 101	0 / 99
serious Total, serious adverse events	0 / 101	0 / 99