EFFICACY OF AUTOLOGOUS PLATELET RICH PLASMA IN THE MANAGEMENT OF PRESSURE ULCER IN PATIENTS WITH SPINAL CORD INJURY

Abstract

Introduction: Pressure ulcers in spinal cord injury represent a challenging problem for patients, their caregivers, and their physicians. They often lead to recurrent hospitalizations, multiple surgeries, and potentially devastating complications. They present a signicant cost to the healthcare system. The incidence of pressure ulcers in the SCI population is 25–66%. Despite treatment, many chronic ulcers fail to heal or persist for months/years and/or recur after healing, requiring additional advanced wound care therapies for adequate healing. Application of autologous Platelet Rich Plasma (PRP) has been a major breakthrough for the treatment of pressure ulcers, as it is an easy and cost-effective method, and provides the necessary growth factors that enhance tissue healing. The purpose of the current study was to determine the safety and effectiveness of treating pressure ulcers with PRP versus a control treatment (normal saline). Material And Methods: In this Open Level Parallel Randomised Controlled Trial, conducted in the Department of Physical Medicine & Rehabilitation, IPGME&R and SSKM Hospital – Kolkata between 1st January 2018-31st June 2019 (18 months). After getting clearance from the Institutional Ethics Committee, Sample size for this study was calculated on the basis of proportion of subject showing complete ulcer healing in 6 weeks on the basis of an earlier study assuming that complete ulcer healing would occur in 20% case in standard wound care (control) and 60% in PRP group (case), it is established that 22 subjects will be required per group (n=44, 22 in each group). Individual informed written consent was taken from each patient to include in the study group. Every patient was explained properly. Those patients who falls under our inclusion criteria will be included for the study. They will be given a proforma and informed consent was taken after base line laboratory investigations. The patients were evaluated clinically. This included a complete medical history including all reports. If the patient fullled the criteria, he or she was put in one of the groups randomly and given PRP as per standard technique. The eschar was adequately removed and pressure ulcer was staged according to the National Pressure Ulcer Advisory Panel & European Pressure Ulcer Advisory Panel. The normal protocol for management of Pressure ulcer at our institute was followed: The pressure ulcer area debrided thoroughly to remove infected tissue and the graded. Group 1(PRP): After PRP injection alternate day dressing was done along with normal saline and Group 2 (Saline): Dressing with normal saline was done daily and repeat debridement are done if needed. PUSH Tool 3.0 & Ulcer area assessment was maintained as per 2 protocol for both the groups. Parameters studied: 1. Area of the ulcer (cm ), 2. Proportion with complete ulcer healing at 6 weeks, 3. PUSH Tool. Patients were assessed at baseline, 2weeks, 4 weeks, 6 weeks then follow up at 3 months. Results: Numerical data were compared between groups using student's unpaired t test when normally distributed or by Mann - Whitney's u test if otherwise. All numerical variables in the descriptive statistics tables were normally distributed by Kolmogorov - Smirnov goodness-of-t test. The Chi – Square test or Fisher's exact test employed for intergroup comparisons of categorical variables. Repeated measures ANOVA followed by Tukey's test was done to compare between two individual time points in both the groups. All analysis was two tailed and p – value <0.05 was considered statistically signicant. In PRP group (case) highest number of patients were between 18-29 & 30-39 years, whereas in saline (control) group highest number of patients were found in the age group of 30-39 years. Mean age of the patients assigned to the PRP group was 36.86 years with a SD of 10.9years and median age was 33.0 years. Mean age of the patients assigned to the Saline (control) group was 37.55 years with a SD of 10.80 years and median age was 35.50 years. In both the groups male preponderance were found, in Case (PRP) 72.73% and in Control (saline) 77.27%. Majority of the ulcer were Grade III (59.09%) in case group and Grade II (54.55%) in control group. Most of the SCI patients with pressure ulcer were due to fall from height (54.55%) in each group. SCI resulting from fall of heavy object on the back was lesser in both the groups. Majority of the pressure ulcer site was sacrum for both the study group (PRP- 59.09%) & (Saline- 54.55%). Majority of the NLI was ASIA C (PRP-40.91% & Saline-45.45%) followed by ASIA B. Unpaired t test revealed that there was no statistically signicant difference between patients of PRP & Saline group in regards to the age of the patient, mean PUSH Tool and mean Area of the ulcer. A statistically signicant difference was found between the two groups when compared for mean PUSH Tool and Area of ulcer at 4wks, 6wks and 3 months. Proportion of the ulcer healed at 6wks was statistically signicant in both the groups (P=0.000). Repeated measures ANOVA followed by Tukey's test was done to compare between two individual time points (ANOVA returns p < 0.05). Repeated measure ANOVA with multiple comparisons show statistically signicant reduction in the mean PUSH tool score of the pressure ulcer in the PRP group when compared to baseline and subsequent visit. Maximum reduction in Mean PUSH Tool 3.0 score (Mean diff = 5.181) was noted in the time period between 6wks to 3 months. Repeated measure ANOVA with multiple comparisons show statistically signicant reduction in the mean Area of the pressure ulcer in the PRP group when compared to baseline and subsequent visit. Maximum reduction in ulcer area (mean diff = 14.705) was observed in the time period between Baseline to 2wks. Repeated measures ANOVA followed by Tukey's test was done to compare between two individual time points (ANOVA returns p < 0.05). Repeated measure ANOVA with multiple comparisons show statistically signicant reduction in the mean PUSH tool score of the pressure ulcer in the Saline group when compared to baseline and subsequent visit. Maximum reduction in Mean PUSH Tool 3.0 score (Mean diff = 6.136) was noted in the time period between 6wks to 3 months. Repeated measure ANOVA with multiple comparisons show statistically signicant reduction in the mean Area of the pressure ulcer in the Saline (control) group when compared to baseline and subsequent visit. However, Tukey's Multiple Comparison test did not show signicant change in reduction of ulcer area in the time period between 4wks to 6wks. Maximum reduction in ulcer area (mean diff = 6.7500) was observed in the time period between Baseline to 2wks. No major complication was seen after treatment with PRP except burning sensation while injecting the PRP at the site of lesion. PRP application hastens the healing process and lead to rapid wound healing. Conclusion: In our study, most of the spinal cord injury patients comprised of male belonging to 2nd and 3rd decade. Most of the spinal cord injury patients were due to fall from height (54.55%). Majority of the ulcer were Grade III (59.09%) in case group and Grade II (54.55%) in control group with sacrum being the site of maximum involvement. PRP group shows signicant reduction in both the PUSH Tool score 3.0 and area of pressure ulcer all throughout the follow up period of 2wks, 4wks, 6wks and 3 months interval (p value <0.001). Saline group also showed signicant reduction in both the PUSH Tool score 3.0 and area of pressure ulcer was noted at 2wks, 4wks, 6wks and 3 months (p value <0.001). But in regard to reduction in ulcer area not much signicant changes was seen between 4 to 6wks. Ulcer healing is more marked, signicant and faster in patients who received autologous PRP along with normal saline. PRP may be an ideal therapy for enhancing wound healing process in pressure ulcer.