Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F, OligoElement Sore Trial Study Group., et al.
Annals of internal medicine. Date of publication 2015 Feb 3;volume 162(3):167-74.
1. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696.
A nutritional formula enriched with arginine, zinc, and antioxidants for the
healing of pressure ulcers: a randomized trial.
Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial
Study Group.
Collaborators: D'Andrea F, Micunco C, Serioli M, Cereda E, Caccialanza R, Bonardi
C, Crespi A, Lombardi A, Andreola E, Gavassa L, De Donà F, Martinoglio P,
Gervasio S, Penoncelli D, Demagistris A, Chiarotto A, Rondanelli M, Perna S,
Rovera LM, Roma M, Gallea A, Pezzana A, Cozza M.
Erratum in
Ann Intern Med. 2015 Dec 15;163(12):964.
BACKGROUND: Trials on specific nutritional supplements for the treatment of
pressure ulcers (PUs) have been small, inconsistent in their formulations, or
unsuccessful in controlling for total supplement calorie or protein content.
OBJECTIVE: To evaluate whether supplementation with arginine, zinc, and
antioxidants within a high-calorie, high-protein formula improves PU healing.
DESIGN: Multicenter, randomized, controlled, blinded trial. (ClinicalTrials.gov:
NCT01107197).
SETTING: Long-term care and home care services.
PATIENTS: 200 adult malnourished patients with stage II, III, and IV PUs.
INTERVENTIONS: An energy-dense, protein-rich oral formula enriched with arginine,
zinc, and antioxidants (400 mL/d) or an equal volume of an isocaloric,
isonitrogenous formula for 8 weeks.
MEASUREMENTS: The primary end point was the percentage of change in PU area at 8
weeks. Secondary end points included complete healing, reduction in the PU area
of 40% or greater, incidence of wound infections, the total number of dressings
at 8 weeks, and the percentage of change in area at 4 weeks.
RESULTS: Supplementation with the enriched formula (n = 101) resulted in a
greater reduction in PU area (mean reduction, 60.9% [95% CI, 54.3% to 67.5%])
than with the control formula (n = 99) (45.2% [CI, 38.4% to 52.0%]) (adjusted
mean difference, 18.7% [CI, 5.7% to 31.8%]; P = 0.017). A more frequent reduction
in area of 40% or greater at 8 weeks was also seen (odds ratio, 1.98 [CI, 1.12 to
3.48]; P = 0.018). No difference was found in terms of the other secondary end
points.
LIMITATION: Participation was restricted to patients who were malnourished, were
able to drink oral supplements, and were living in long-term care institutions or
receiving home care services.
CONCLUSION: Among malnourished patients with PU, 8 weeks of supplementation with
an oral nutritional formula enriched with arginine, zinc, and antioxidants
improved PU healing.
PRIMARY FUNDING SOURCE: Azienda Ospedaliera Universitaria Maggiore della Carità.
DOI: 10.7326/M14-0696
PMID: 25643304 [Indexed for MEDLINE]
