Emanuele Cereda, MD, PhD; Catherine Klersy, MD, MSc; Marcella Serioli, RD; Aldo Crespi, MD; Federico D'Andrea, MD; for the OligoElement Sore Trial Study Group (*)
Acknowledgment: The authors thank all of the health care professionals and caregivers, who did not receive compensation beyond their normal salaries, for their assistance with recruitment and data collection. The authors also thank Dr. Jennifer S. Hartwig for assistance in editing the manuscript.
Grant Support: By the Azienda Ospedaliera Universitaria Maggiore della Carità.
Disclosures: None. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-0696.
Reproducible Research Statement:Study protocol and statistical code: Available from Dr. Cereda (email, firstname.lastname@example.org). Data set: Not available.
Requests for Single Reprints: Emanuele Cereda, MD, PhD, Servizio di Dietetica e Nutrizione Clinica, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Viale Golgi 19, 27100 Pavia, Italy; e-mail, email@example.com.
Current Author Addresses: Drs. Cereda and Klersy: Servizio di Dietetica e Nutrizione Clinica, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Viale Golgi 19, 27100 Pavia, Italy.
Drs. Serioli and D'Andrea: Struttura Complessa a Direzione Ospedaliera Dietetica e Nutrizione Clinica, Azienda Ospedaliera Universitaria Maggiore della Carità, Corso Mazzini 18, 28100 Novara, Italy.
Dr. Crespi: Struttura Semplice di Prevenzione e Cura Lesioni Vascolari, Azienda Sanitaria Locale Novara (ASL NO), Viale Roma 7, 28100 Novara, Italy.
Author Contributions: Conception and design: E. Cereda, A. Crespi, F. D'Andrea.
Analysis and interpretation of the data: E. Cereda, C. Klersy.
Drafting of the article: E. Cereda.
Critical revision of the article for important intellectual content: E. Cereda, C. Klersy, M. Serioli, A. Crespi, F. D'Andrea.
Final approval of the article: E. Cereda, C. Klersy, M. Serioli, A. Crespi, F. D'Andrea.
Provision of study materials or patients: E. Cereda, A. Crespi, F. D'Andrea.
Statistical expertise: C. Klersy.
Obtaining of funding: F. D'Andrea.
Administrative, technical, or logistic support: E. Cereda, M. Serioli, A. Crespi, F. D'Andrea.
Collection and assembly of data: E. Cereda, M. Serioli, A. Crespi.
Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F, for the 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;162:167-174. doi: 10.7326/M14-0696
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Published: Ann Intern Med. 2015;162(3):167-174.
This article has been corrected. The original version (PDF) is appended to this article as a Supplement.
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.
To evaluate whether supplementation with arginine, zinc, and antioxidants within a high-calorie, high-protein formula improves PU healing.
Multicenter, randomized, controlled, blinded trial. (ClinicalTrials.gov: NCT01107197)
Long-term care and home care services.
200 adult malnourished patients with stage II, III, and IV PUs.
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.
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.
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.
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.
Among malnourished patients with PU, 8 weeks of supplementation with an oral nutritional formula enriched with arginine, zinc, and antioxidants improved PU healing.
Azienda Ospedaliera Universitaria Maggiore della Carità.
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