Platelet-rich Plasma in Skin Ulcer Treatment

Raquel Cobos Campos, Pharm; Naiara Parraza Diez, Pharm, PhD; Felipe Aizpuru Barandiaran, MD, PhD

Disclosures

Wounds. 2013;25(9):256-262. 

In This Article

Discussion

Using a Markov model, the authors simulated the clinical course of skin ulcers with a hypothetical cohort of 200 patients randomly assigned to either receive standard care consisting of cleansing of the wound, debridement of necrotic tissue, prevention, diagnosis, and if required, treatment of infection, and the application of suitable dressings; or to receive PRP in addition to standard care. The effectiveness and costs of the 2 treatment options after 48 weeks was then compared.

After 48 weeks of treatment, the overall estimates of effectiveness were 56% for the PRP group and 31% for the standard care group, while the estimated costs were €5224 and €5133, respectively. The NNT was 4 patients. Adding PRP to usual care to achieve healing of 1 additional ulcer required an additional cost of €364, rising to €1546 in the worst case scenario (calculating the incremental cost using data from the literature giving the smallest difference in effectiveness between the treatments).

Furthermore, it should be borne in mind that in the calculations the authors have only considered the direct costs related to the health system. Indirect costs (such as lost productivity due to absenteeism, or sick leave and transport costs) have not been taken into account since they are difficult to quantify, but given the lower rate of healing and higher rate of amputations among those receiving usual care, it can be assumed indirect costs would be higher in this group.

Intangible costs (in particular, deterioration in quality of life caused by patient disability and pain due to the wounds) are particularly difficult to quantify in financial terms, and hence, have not been taken into account in this study. It would, however, be important to assess their impact in future studies, since pain is a symptom which is perceived by patients as a constant reminder of their ulceration and is also hard to control.[25] Intangible costs can also be expected to be higher in the group receiving standard care given the lower rate of ulcer healing. In addition, the values of costs and effectiveness have been estimated for a time period of just under 1 year. An ulcer that has not healed after 52 weeks of treatment is considered unlikely to heal; however, the costs continue to increase since the probability of amputation at 5 years is 19%,[18] so the overall costs associated with treating an ulcer after 5 years would be higher, especially in the group receiving the standard care, since there would be a higher rate of amputation.

Another important factor to take into account is the limited number of clinical trials identified with the required outcome variable as the main assessment criterion. Further more, of the 4 studies reviewed, only 1 other made reference to vascular ulcers, with the other 3 focusing on the use of PRP in diabetic ulcers. In theory, this is unlikely to pose a problem given that diabetic ulcers have a poorer prognosis than vascular ones in general, and it can be assumed that if PRP is effective in diabetic ulcers, it would be at least as effective, or more effective, in vascular ulcers. In addition, in 2 of the 4 selected studies, the authors have estimated the number of ulcers healed at 12 weeks from the available data for 8 weeks and 20 weeks. This estimate has been performed considering the process of wound healing follows linear kinetics, but in actuality, wound healing depends on several factors such as age, infection presence, degree of nutrition, and length of time since development of the ulcer.

Despite the aforementioned limitations, the authors think this study has strengths. In particular, a thorough search of the scientific literature selecting the most homogenous studies was conducted, which allowed the authors to calculate a robust combined estimate of effectiveness, the starting point for the estimate of the probability of healing after 48 weeks of treatment. Further, the authors selected as the measure of the effect an outcome variable, namely the number of ulcers healed at the end of the study, that made the criteria for this study's literature search more exacting, as in many studies the variable measured is the percentage reduction in ulcer size.

It would be interesting to perform a cost-effectiveness analysis within a clinical trial in order to address the aforementioned limitations. Further, it would be desirable to assess these treatments from a social perspective, considering factors important for patients such as quality of life, especially pain, and also to carry out a 5-year follow-up as completed several years ago by Dougherty,[18] who obtained a positive cost-effectiveness ratio using PRP in diabetic ulcers.

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