Trial Outcomes & Findings for Nutritional Support in Pressure Ulcer Patients (NCT NCT01107197)
NCT ID: NCT01107197
Last Updated: 2014-02-12
Results Overview
healing is defined as reduction in ulcer area (the percentage of change)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
8 weeks of nutritional support (baseline and week 8)
Results posted on
2014-02-12
Participant Flow
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.
Participant milestones
| Measure |
Isonitrogenous Isocaloric Formula
Patients were given standard diet plus 2 bottles/day (200 mL each; in 4 boluses \[100 mL each\] spread throughout the day) of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one for 8 weeks
Control formula : Isonitrogenous isocaloric oral formula
|
Enriched Nutrition Formula
Patients were given standard diet plus two bottles/day (400 mL) of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements for 8 weeks
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
|
Overall Study
COMPLETED
|
79
|
78
|
|
Overall Study
NOT COMPLETED
|
20
|
23
|
Reasons for withdrawal
| Measure |
Isonitrogenous Isocaloric Formula
Patients were given standard diet plus 2 bottles/day (200 mL each; in 4 boluses \[100 mL each\] spread throughout the day) of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one for 8 weeks
Control formula : Isonitrogenous isocaloric oral formula
|
Enriched Nutrition Formula
Patients were given standard diet plus two bottles/day (400 mL) of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements for 8 weeks
Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements
|
|---|---|---|
|
Overall Study
Death
|
12
|
10
|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Nutritional Support in Pressure Ulcer Patients
Baseline characteristics by cohort
| Measure |
Enriched Nutrition Formula
n=78 Participants
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
|
Isonitrogenous Isocaloric Formula
n=79 Participants
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
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
73 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Age, Continuous
|
80.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
81.2 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
80.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
78 participants
n=5 Participants
|
79 participants
n=7 Participants
|
157 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks of nutritional support (baseline and week 8)healing is defined as reduction in ulcer area (the percentage of change)
Outcome measures
| Measure |
Enriched Nutrition Formula
n=78 Participants
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
|
Isonitrogenous Isocaloric Formula
n=79 Participants
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
|
|---|---|---|
|
Rate of Healing
|
62.9 percent change
Standard Deviation 29.1
|
43.4 percent change
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: 8 weeks of nutritional support (baseline and week 8)reduction in ulcer area \>=40%
Outcome measures
| Measure |
Enriched Nutrition Formula
n=78 Participants
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
|
Isonitrogenous Isocaloric Formula
n=79 Participants
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
|
|---|---|---|
|
Rate of Healing
|
57 participants
|
41 participants
|
SECONDARY outcome
Timeframe: 8 weeks of nutritional support (baseline and week 8)complete healing
Outcome measures
| Measure |
Enriched Nutrition Formula
n=78 Participants
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
|
Isonitrogenous Isocaloric Formula
n=79 Participants
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
|
|---|---|---|
|
Rate of Healing
|
12 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 8 weeks of nutritional support (baseline and week 8)defined as local (ulcer)
Outcome measures
| Measure |
Enriched Nutrition Formula
n=78 Participants
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
|
Isonitrogenous Isocaloric Formula
n=79 Participants
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
|
|---|---|---|
|
Incidence of Infections
|
9 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Enriched Nutrition Formula
n=78 Participants
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
|
Isonitrogenous Isocaloric Formula
n=79 Participants
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
|
|---|---|---|
|
Cost-effectiveness
|
639 Euros
Standard Deviation 213
|
689 Euros
Standard Deviation 247
|
SECONDARY outcome
Timeframe: 8 weeks of nutritional support (baseline and week 8)The number of dressings used throughout the intervention period
Outcome measures
| Measure |
Enriched Nutrition Formula
n=78 Participants
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
|
Isonitrogenous Isocaloric Formula
n=79 Participants
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
|
|---|---|---|
|
Dressings
|
31 dressings
Standard Deviation 13
|
35 dressings
Standard Deviation 13
|
SECONDARY outcome
Timeframe: 4 weeks of nutritional support (baseline and week 4)the reduction in ulcer area (%) observed at 4 weeks
Outcome measures
| Measure |
Enriched Nutrition Formula
n=78 Participants
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
|
Isonitrogenous Isocaloric Formula
n=79 Participants
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
|
|---|---|---|
|
the Percentage of Change in Area
|
29.3 percent change
Interval 13.9 to 58.9
|
21.9 percent change
Interval 5.6 to 38.1
|
Adverse Events
Enriched Nutrition Formula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Isonitrogenous Isocaloric Formula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Federico D'Andrea
Department of Clinical Nutrition and Dietetics, Azienda Ospedaliera "Maggiore della Carità"
Phone: +39 0321.373.3275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place