Exploring Nursing Practice

Research Article 1

Meaume, S., Kerihuel, J. C., Constans, T., Teot, L., Lerebours, E., Kern, J., & Marchasson, I. B. (2009). Efficacy and safety of ornithine alpha-ketoglutarate in heel pressure ulcers in elderly patients: results of a randomized controlled trial. JNHA-The Journal of Nutrition, Health and Aging13(7), 623.r

Introduction to Pressure Ulcer and Nutrition

This article explores the use of Ornithine alphaketoglutarate (OKG) for enhancing healing process of skin. Meaume et al. (2009) had aimed to determine the OKG efficacy in reducing the pressure ulcer areas in six weeks of treatment. The design of this study was randomized, controlled, multicenter, double blind, placebo-controlled, parallel groups and international. They took 160 participants aged over 60 years who were suffering from heel pressure ulcers at the stage of II or III.

In their study methodology, OKG was given to 85 patients (placebo, n=75), once daily for six weeks. The area of the ulcer was measured using tracer every week. Percentage reduction in this area at the final visit was taken as the primary endpoint. The study results indicated that at inclusion, the ulcer area distribution was deviating from the normal distribution. The major bias in this study was the abnormal distribution as the healing is related strongly to the baseline area of ulcer. Hence, they performed analysis on two subgroups according to the mean area of ulcer and these were below or above 8cm2.

This study concluded that the use of OKG is beneficial for the elderly patient having ulcers ≤ 8 cm2 associated with debridement and proper wound management. This has to be given 10g daily and the pressure ulcer guidelines have to be followed. However, this study suffered from the limitations of methodological difficulties in performing clinical trial in very old patient and this might affect the robustness of the study results.

Critique

The selected article recognizes the nutritional status as a risk factor for the pressure ulcers in the elderly population. The introduction provides a brief overview of the literature on OKG use and this provided rationale for the study and as guidance for the methodology that can be adopted. Meaume et al. (2009) had recognized that the efficacy of OKG in different clinical settings have been evaluated by pervious research scholars. There results obtained in these studies were in favor of OKG however, these were performed with small size, single center and on heterogenous wound in terms of baseline stages and location. Therefore, the literature on this topic is not sufficient to address the use of OKG in elderly population suffering from pressure ulcers.

There are both primary and secondary objectives in this study however a hypothesis is not given. The eligibility criteria for the study population has been clearly defined and the exclusion criteria are also given. These criteria were given in accordance with the study objectives so that the factors affecting the result study are eliminated at this stage. For instance, patients suffering from diabetes that is poorly controlled were eliminated in this study as wounds in such patients takes time to heal and therefore, this would have impacted the results of this study.

The study had described the wound management protocol and this was according to the French consensus conference. The concomitant treatment was also sufficiently detailed in this study. The methods for clinical assessment along with the time interval was detailed. The selection of the sample size was not based on any calculation rather it was determined on the basis of earlier researches which was minimum of 70 patients in each group. CRISTAL software was used for randomization. The description of the randomization process was short and it mentioned the sizes of the block. AUTOCAD software was used for the tracing of the ulcers in the study population which eliminated the possible of error in ulcer area measurement.

The primary efficacy criterion was done using the ANCOVA software on the lesion history, basis of age and weight of patient and these were the covariables. The efficacy analysis was done on the intent to treat (ITT) population and the principle of Last Observation Carried Forward (LOCF) was used for dealing with the missing efficacy time-points. These steps have helped in enhancing the quality of this study. As per the objective of the study, the choice of randomized-controlled trial was suitable as it helps in the determination of the drug efficacy in the study population in contrast to the placebo. The statistical analysis, measurement of outcome and the methodology of the treatment was detailed properly. Therefore, the outside researchers can attempt to verify the study results. The study also described the ITT analysis adequately.

This study has a merit in terms of wound management and care as this was done as per the god clinical guidelines and practice. A standardized program for giving appropriate wound care was given to the ITT population. This program covered aspects of wound care and included the infection control, moist environment, pressure avoidance and sharp debridement. Additionally, the study cited the difficulties in carrying out RCTs in very old patients as many of the patients suffered from adverse events during the course of OKG administration. ITT population had only suffered from mild to moderate side effects of this drug which was already known in the literature. The results of the study are described clearly and have been supported by tables and figures. Appendix is however missing in this study which could have given it more authenticity. The discussion of the study is elaborate and the results are related to the study outcomes.

Proper nutrition has been found to positively impact the healing process of the pressure ulcers. The use of the OKG has been researched in boosting the healing process of the pressure ulcers (Saghaleini, et al 2018). The specific use of this drug in the pressure ulcers of heel of patients have also been documented (Rivolo, 2016). This study provides strong favor for the use of OKG in the management of pressure ulcers in elderly patients. This drug has been found to boost the healing process as it is a precursor to various types of amino-acids. It was highlighted in this study that after first two weeks of treatment this drug showed a ‘booster effect’ and there was an accelerated rate of wound closure in contrast to the placebo population. By week 6, there was a higher reduction in the wound area (by ≥ 90%). Recommendations for further study have not been provided and this is a major drawback of this paper. Overall, this paper is of high quality and therefore, the OKG drug can be given in clinical settings to the elderly patients for enhancing the healing process of pressure ulcers of heels.

References for Pressure Ulcer and Nutrition

Meaume, S., Kerihuel, J. C., Constans, T., Teot, L., Lerebours, E., Kern, J., & Marchasson, I. B. (2009). Efficacy and safety of ornithine alpha-ketoglutarate in heel pressure ulcers in elderly patients: results of a randomized controlled trial. JNHA-The Journal of Nutrition, Health and Aging13(7), 623.r

Rivolo, M. (2016). The evidence for treating pressure injury located on the patient’s heel. Journal of Community Nursing30(3).

Saghaleini, S. H., Dehghan, K., Shadvar, K., Sanaie, S., Mahmoodpoor, A., & Ostadi, Z. (2018). Pressure ulcer and nutrition. Indian journal of critical care medicine: peer-reviewed, official publication of Indian Society of Critical Care Medicine22(4), 283.

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