| Abstract |
INTRODUCTION
The healing process is the natural, continuous, systematic and dynamically evolving wound repair reaction that is divided into the following overlapping phases: a) inflammatory phase (first 2-5 days), b) proliferation phase (2nd day until 3rd week) and c) phase of maturation/ remodeling phase (3rd week until 2 years).
The stages of healing are common to all tissues. Of particular interest are chronic wounds, which need long time in order to be healed. Chronic ulcers are defined as the ulcers that persist for a period more than 3 months, as a result of disruption of the healing process, which normally would lead to the formation of scar.
In the treatment of chronic ulcers, various topical treatments are used to stimulate and accelerate healing by acting on one or more of the above-mentioned phases. These treatments include the application of autologous concentrated plasma. Due to its high content in platelets, it is also called Platelet-Rich-Plasma (PRP) or Autologous Preparation Rich in Growth Factors (PRGF).
However, the clinical efficacy of PRP in chronic ulcers is not widely accepted. There are systematic reviews and meta-analyses with contradictory results, with supporters of ineffectiveness relying mainly on systematic biases of published studies.
AIM
The aim of this prospective study is to objectively assess the impact of PRP therapy on healing of chronic wounds, utilizing digital planimetry and using a mathematical model. Such study has not yet been reported in the literature.
MATERIAL
In the two-year study, 43 patients with chronic pressure ulcers were prospectively enrolled. The study was approved by the local ethic commission and all patients provided written informed consent prior to participation. Eligible subjects were patients with pressure ulcers with a surface larger than 1 cm2 and presence longer than three months. Exclusion criteria were poor general condition (Karnofsky index <60%), and significant comorbidity, such as severe or uncontrolled cardiac or pulmonary disease, malignant or premalignant marrow disorder disease (e.g. myeloid leukemia or myelodysplastic syndrome), kidney or liver failure, cerebral vascular disorders, coma, intracranial hypertension or accompanying autoimmune diseases. Patients with chronic ulcers smaller than 1cm2, very deep ulcers with cavities, facial ulcers, as well as pregnant and lactating women were also excluded from the study.
METHOD
In each patient, surgical debridement of all the ulcers was performed and was followed by a period of 4 weeks, in which the patient continued the conservative treatment applied before joining the study. To minimize the impact of various wound healing impairing factors, attempts were made to improve underlying diseases (correction of diabetes, improvement of nutritional status, oxygen therapy, etc.) before the patient was enrolled in the study.
After this time, a re-debridement was performed when needed. Subsequently, PRP was injected locally to the ulcer margins and bed and the patient was observed for 4 more weeks. PRP was prepared by centrifuging 30-60 ml of the patient’s blood with an autologous platelet separator (Medtronic Magellan MAG100 Autologous Platelet Separator System) at 2000 rpm for 3 minutes and then at 5000 rpm for 5 minutes. PRP was then administered on the wound. The wound was then covered with a transparent, non-adhering dressing. The injection was repeated once a week for 4 weeks. During the period of PRP treatment, no local creams or dressings with potential healing action were allowed.
The treatment’s effectiveness was weekly assessed with digital planimetry during the 8-week study period. Digital photos were obtained with the same digital camera with standardized settings at a constant distance with a ruler next to the wound for scaling. Two-dimensional digital planimetry using non-commercial software developed by one of the investigators provided objective wound-area measurements from the digital images. Since debridement, performed at the beginning of the conservative treatment period and when necessary at the beginning of the PRP treatment, delays the start of the wound healing process for a few days, the first measurements for the assessment of the subsequent healing time were at the end of the first and fifth week, respectively.
RESULTS
Forty-three patients with 74 chronic pressure ulcers with median age 58 years were primarily enrolled in the study. Of these, 2 patients were healed during conventional treatment. Two patients died due to multi-organ failure during the 3rd and 5th study week and were therefore excluded from the study. Three patients discontinued their participation during the study period.
The final sample consisted of 36 patients (22 males, 14 females) with 64 chronic ulcers and a mean age of 62 years, median age 58 years (range 38-88). Of the 64 lesions, 44 were located in the sacrogluteal region, 10 at the heel, 2 on the thigh, 3 on the tibial region, 3 on the ankle, 1 on the abdominal wall and 1 at the stump end after high tibial amputation.
The ulcers had following size at the first measurement (i.e. at the end of the first week): Median surface was 19.6 cm2 (3-180 cm2), median diameter was 6.3 cm (1.3-18.6 cm) and median circumference was 16.8 cm (4-68 cm). At the end of the fourth week, median surface was 11 cm2 (2-155 cm2, decrease 41%), median diameter was 4.9 cm (1-16.5 cm, decrease 20%) and median circumference was 13.2 cm (3-55 cm, decrease 21%).
At the beginning of the fifth week PRP was applied. The reference values for PRP, at the end of the fifth week were: median surface 8.2 cm2 (2-145 cm2), median diameter 4.4 cm (1-16 cm) and median circumference 11.8 cm (3-50 cm). Ulcer size values were weekly obtained and at the end of the eighth week the ulcers had a median surface of 2.9 cm2 (0-115 cm2, 63% decrease), median diameter was 2.8 cm (0-13.3 cm, 33% decrease) and median circumference was 7.3 cm (0-42 cm, 38% decrease). This represents a decrease of 63% for the median surface, 33% for the median diameter and 38% of the median circumference. Reduction of all these parameters was statistically significantly greater (p<0.001) than during the conservative treatment period.
CONCLUSIONS
Autologous concentrated plasma (PRP) accelerated healing of chronic pressure ulcers in the present study, resulting in a statistically significant compared to conventional methods, reduction of ulcerative surface, which is the most reliable indicator for wound healing.
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Αξιολόγηση της αποτελεσματικότητας του αυτόλογου συμπυκνωμένου πλάσματος στην επιτάχυνση της επούλωσης χρόνιων ελκών με υπολογιστική πλανιμετρία και μαθηματική προτυποποίηση
