Superabsorbent Wound Dressing for Management of Patients With Moderate-to-Highly Exuding Chronic Leg Ulcers: An Early Stage Model-Based Benefit-Harm Assessment
The international journal of lower extremity wounds. 2021;:15347346211009399
The aim of the research is to assess the benefit-harm of superabsorbent polymers wound dressings based on polyacrylate polymers (SAPs) compared with standard of care (SoC) dressing mix for patients with moderate-to-highly exuding hard-to-heal leg ulcers. The SoC dressings mix was composed of other superabsorbents in 29% of cases, antimicrobials 26%, foams 20%, alginates 5%, and other dressings 19% weighted according to their frequency. We have used the decision-analytic modeling method, Markov process, as an adequate analytical solution for medical prognosis. We have combined the systematic literature search to identify the most relevant inputs for the analysis, with available patient-level clinical data concerning benefits of superabsorbent to generate a robust prediction of patient-relevant outcomes, including healing rates and health-related quality of life. Besides, we have qualitatively described adverse events associated with those treatments. Our research indicates that SAPs when compared with SoC dressing mix in a patient with moderate-to-highly excluding leg ulcers are leading to an improved healing rate with an absolute risk difference of 2.20% in 6 months and a relative risk of 1.07 in favor of SAP dressings. The attributable fraction among those exposed to SAP dressings of 6.6%, meaning that 6.6% of the healed ulcers could be attributed to having had the SAP dressing treatment instead of the SoC dressing treatment. Besides, SAP dressings lead to improved quality of life measured as incremental quality-adjusted life weeks (QALWs) of 0.13 QALWs.
The application of platelet-rich plasma in the treatment of knee osteoarthritis: A literature review
Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association. 2021
BACKGROUND Primary knee osteoarthritis remains a difficult-to-control degenerative disease. With the rise in average life expectancy and the incidence of obesity, osteoarthritis has brought an increasing economic and physical burden on people. This article summarizes the latest understanding of platelet-rich plasma in the treatment of knee osteoarthritis, and reviews the economic issues of PRP. METHODS The literatures in Pubmed, Embase, Cochrane library, Web-science and other databases were searched, and literature inclusion and exclusion criteria were formulated. According to the Cochrane systematic reviewer's manual, the included literatures were grouped, and qualitative descriptions and quantitative meta-analysis were performed. Continuous statistical methods were used to compare the effects and adverse effects of PRP before and after treatment, as well as between PRP and other conservative treatments. RESULTS A total of 12 randomized controlled trials were included in this study. A total of 959 KOA patients (1070 knees) were enrolled and followed for 3-12 months. PRP total knee scores were significantly better than baseline at 1, 2, 3, 6 and 12 months after treatment (1 month: SMD = 0.60, P < 0.01; 2 months: SMD = 0.98, P < 0.01; 3 months: SMD = 1.16, P < 0.01; 6 months: SMD = 1.49, P < 0.01; 12 months: SMD = 1.47, P < 0.01). In terms of adverse reactions, PRP did not increase the risk of adverse events compared with HA (OR = 0.96, P = 0.85). CONCLUSIONS Compared with many other treatment methods, intra-articular injection of PRP has been proven to be safe and effective to improve the quality of life of patients with KOA.
Efficacy of Platelet-Rich Plasma Versus Placebo in the Treatment of Tendinopathy: A Meta-analysis of Randomized Controlled Trials
Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine. 2021
OBJECTIVE To evaluate the efficacy of platelet-rich plasma (PRP) injections versus placebo in the treatment of tendinopathy. DATA SOURCES We performed a systematic literature search in MEDLINE, Embase, Scopus, CINAHL, Cochrane Library, and ClinicalTrials.gov through November 2020 to identify randomized controlled trials (RCTs) that evaluated the clinical efficacy of PRP versus placebo for the treatment of tendinopathy. Outcomes were analyzed on an intention-to-treat basis with random-effects models. MAIN RESULTS A total of 13 RCTs were included in this meta-analysis. The pooled analysis showed no significant difference in pain relief at 4 to 6 weeks (standard mean difference [SMD]: -0.18, 95% confidence intervals [CI]: -0.62 to 0.26), 12 weeks (SMD: -0.14, 95% CI: -0.55 to 0.26), and ≥24 weeks (SMD: -0.56, 95% CI: -1.16 to 0.05) or function improvement at 4 to 6 weeks (SMD: 0.11, 95% CI: -0.13 to 0.35), 12 weeks (SMD: 0.18, 95% CI: -0.13 to 0.49), and ≥24 weeks (SMD: 0.26, 95% CI: -0.14 to 0.66) for PRP compared with placebo in the treatment of tendinopathy. The sensitivity analysis indicated no significant difference in pain relief or function improvement at 12 weeks between PRP and placebo for different types of tendinopathies, treatment regimens, leukocyte concentrations, or cointerventions. CONCLUSIONS Platelet-rich plasma injection was not found to be superior to placebo in the treatment of tendinopathy, as measured by pain relief and functional improvement at 4 to 6, 12, and ≥24 weeks.
Platelet-Rich Plasma Combined With Autologous Grafting in the Treatment of Long Bone Delayed Union or Non-union: A Meta-Analysis
Frontiers in surgery. 2021;8:621559
Background: Platelet-rich plasma (PRP) has been suggested as an emerging treatment for bone defects. However, whether PRP could enhance the therapeutic efficacy of autologous bone grafting for long bone delayed union or non-union remains unknown. A meta-analysis of randomized and non-randomized controlled trials (RCT and NRCT) was performed to summarize current evidence. Methods: Relevant RCTs and NRCTs comparing the influences of autologous bone grafting on healing of long bone delayed union or non-union with and without PRP were obtained by searching PubMed, Embase, Cochrane's Library, China National Knowledge Infrastructure, and WanFang databases from inception to September 10, 2020. A random-effect model was applied to pool the results with the incorporation of the potential heterogeneity. Subgroup analysis according to study design was also performed. Results: Six RCTs and two NRCTs with 420 patients were included. Compared to patients allocated to autologous bone grafting alone, those allocated to combined treatment with PRP and autologous bone grafting were not associated with higher rates of radiographic bone healing [risk ratio (RR): 1.06, 95% confidence interval (CI): 0.99-1.13, P = 0.09; I (2) = 24%] or excellent/good posttreatment limb function (RR: 1.14, 95% CI: 0.95-1.37, P = 0.37; I (2) = 0%) but was associated with a shorter healing time (mean difference: -1.35 months, 95% CI: -1.86 to -0.84, P < 0.001; I (2) = 58%). Subgroup analysis according to study design showed similar results for the above outcomes (P-values for subgroup difference all >0.10). Conclusions: Combined treatment with PRP and autologous bone grafting may be effective to accelerate the healing of long bone delayed union or non-union compared to autologous bone grafting alone.
The Effectiveness and Safety of Platelet-Rich Plasma for Chronic Wounds: A Systematic Review and Meta-analysis
Mayo Clinic proceedings. 2021
OBJECTIVE To evaluate the effectiveness and adverse events of autologous platelet-rich plasma (PRP) in individuals with lower-extremity diabetic ulcers, lower-extremity venous ulcers, and pressure ulcers. PATIENTS AND METHODS We searched multiple databases from database inception to June 11, 2020, for randomized controlled trials and observational studies that compared PRP to any other wound care without PRP in adults with lower-extremity diabetic ulcers, lower-extremity venous ulcers, and pressure ulcers. RESULTS We included 20 randomized controlled trials and five observational studies. Compared with management without PRP, PRP therapy significantly increased complete wound closure in lower-extremity diabetic ulcers (relative risk, 1.20; 95% CI, 1.09 to 1.32, moderate strength of evidence [SOE]), shortened time to complete wound closure, and reduced wound area and depth (low SOE). No significant changes were found in terms of wound infection, amputation, wound recurrence, or hospitalization. In patients with lower-extremity venous ulcers or pressure ulcers, the SOE was insufficient to estimate an effect on critical outcomes, such as complete wound closure or time to complete wound closure. There was no statistically significant difference in adverse events. CONCLUSION Autologous PRP may increase complete wound closure, shorten healing time, and reduce wound size in individuals with lower-extremity diabetic ulcers. The evidence is insufficient to estimate an effect on wound healing in individuals with lower-extremity venous ulcers or pressure ulcers. TRIAL REGISTRATION PROSPERO Identifier: CRD42020172817.
Treatment of knee osteoarthritic pain with platelet-rich plasma: a systematic review of clinical studies
Pain management. 2021
Introduction: Knee osteoarthritis is a degenerative joint disease that is secondary to degradation of articular cartilage, reformation of subchondral bone through degradation and proliferation as well as presence of synovitis. Materials & methods: This systematic review was conducted and reported as per Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Results: A total of 30 of the 48 comparators showed statistically significant superiority with platelet-rich plasma (PRP) compared with a control, while the other 16 comparators showed no significant difference between PRP and the comparator. Conclusion: We can only recommend PRP for patients with early-stage osteoarthritis (I or II) and who are aged below 65, based on our findings. Based on the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) recommendations, while studies reviewed were randomized controlled studies, and therefore, high grade, due to variance in imprecision, risk of bias and inconsistency among the 37 studies, it would be reasonable to rate this paper as subjectively moderate.
Prospective, double-blind, randomized, placebo-controlled phase III study evaluating efficacy and safety of octagam 10% in patients with dermatomyositis ("ProDERM Study")
INTRODUCTION Dermatomyositis (DM) is an inflammatory myopathy characterized by distinct skin manifestations and muscle weakness. Intravenous immunoglobulin (IVIg) has been used off-label as adjuvant therapy in DM, but is not indicated for DM, due to lack of proven efficacy in a large randomized controlled trial. The objective of the ProDERM (Progress in DERMatomyositis) study was to evaluate the efficacy, safety and long-term tolerability of IVIg (Octagam 10%) in patients with DM in a randomized, placebo-controlled, double-blind, Phase III study. METHODS Adult patients with active DM who were continuing standard therapy at a stable dose were eligible for this study. Patients were randomized 1:1 to receive either 2 g/kg of IVIg or placebo, administered every 4 weeks until week 16 (First Period). Patients were switched to the alternate treatment if they showed clinical deterioration in the First Period. After response assessment at week 16, all patients on placebo and those without deterioration on IVIg entered the open-label Extension Period, receiving 2 g/kg IVIg every 4 weeks for 24 weeks. RESULTS The primary efficacy endpoint was the proportion of responders in the IVIg vs placebo arm at week 16, where response was defined per 2016 ACR/EULAR Myositis Response Criteria of at least minimal improvement [Total Improvement Score (TIS) ≥20] and without deterioration at 2 consecutive visits up to week 16. TIS consists of composite response criteria, combining weighted improvement in 6 core set measures (CSMs), Global Disease Activity (Physician and Patient), manual muscle testing-8 (MMT-8), Health Assessment Questionnaire, extra-muscular disease activity, and muscle enzymes. Secondary endpoints included the mean change in individual CSMs, time to improvement in TIS, time to confirmed deterioration in the First Period, and the overall proportion of patients with deteriorations. Adverse events, including infusion reactions and thromboembolic events, were recorded. CONCLUSIONS The ProDERM study was the first to assess the long-term efficacy and safety of IVIg (Octagam 10%) in a placebo-controlled, blinded, randomized trial in DM. The study aimed to inform on the use of IVIg in the treatment of DM, and results are expected in Q3 2020. CLINICALTRIALSGOV IDENTIFIER NCT02728752.
Efficacy of autologous platelet-rich plasma gel in the treatment of refractory pressure injuries and its effect on wound healing time and patient quality of life
Clinics (Sao Paulo, Brazil). 2021;76:e2355
OBJECTIVES To evaluate the efficacy of autologous platelet-rich plasma (PRP) gel in the treatment of refractory pressure injuries and its effect on wound healing time and quality of life of patients. METHODS A random number table method was used to group 102 patients with refractory pressure injuries into either a control group (CG) (51 cases) receiving negative pressure wound therapy (NPWT) or a study group (SG) (51 cases) receiving NPWT+PRP gel. RESULTS The total efficacy rate in the SG (92.16%) was higher than that in the CG (76.47%) (p<0.05). The SG exhibited lower visual analog scale (VAS) scores and pressure ulcer scale for healing (PUSH) scores, smaller wound sizes and depths, and shorter wound healing times than the CG after 21 days of treatment (p<0.05). After 6 months of treatment, the SG scored higher than the CG on the psychological, physiological, social functions, and daily activity domains on the World Health Organization Quality of Life (WHOQOL-BREF) scale (p<0.05). The incidence of postoperative complications in the SG (13.73%) was not significantly different from that of the CG (7.84%) (p>0.05). CONCLUSION In the treatment of refractory pressure injuries, PRP gel can accelerate wound healing, reduce wound pain, shorten the treatment cycle, regulate tissue inhibitor matrix metalloproteinase-1 (TIMP-1) and matrix metalloproteinase-9 (MMP-9) levels and the expression of specific proteins in granulation tissue, reduce the levels of the inflammatory factors interleukin-1β (IL-1β), IL-8, and tumor necrosis factor-α (TNF-α), and improve the quality of life of patients without increasing complications.
The Role of Autologous Platelet Concentrates in the Treatment of Medication-Related Osteonecrosis of the Jaw
The Journal of craniofacial surgery. 2021;32(2):621-625
The frequent refractory response of patients to the treatment of medication-related osteonecrosis of the jaw (MRJON) has attracted clinicians' attention to several treatments. However, they are at best, palliative, and have a higher failure rate than previous treatments. The present meta-analysis was performed to evaluate the clinical effectiveness of autologous platelet concentrates (APCs) combined with surgery in the treatment of MRONJ. The authors conducted a meta-analysis involving a systematic search of PubMed, EMBASE, Wiley Online Library and the Cochrane Library for eligible studies from their inception to November 2019, in accordance with preselected criteria. The inverse variance method was applied to fixed or random effects models based on the heterogeneity of the studies. Thirteen studies that investigated APCs in the treatment of MRONJ were eligible for inclusion in the meta-analysis of 223 patients and 33 lesions. The pooled success rate of APCs combined with surgery for MRONJ was 90% (95%CI, 80%-97%) and the pooled OR was 7.67 (95%CI, 2.10-27.98), indicating the combination was 7.67 times more effective than surgery alone. The results suggest that the use of APCs is a promising therapeutic regimen, as it provided additional benefits to surgery in the treatment of MRONJ. To achieve the benefits, a tension-free primary closure of the soft tissue is recommended as well. Randomized studies with large sample sizes is warranted to confirm our finding.
Intra Articular Injection Of Autologous Microfat And Platelet-Rich Plasma In The Treatment Of Knee Osteoarthritis: A Double Blind Randomized Comparative Study
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 2021
PURPOSE Compare a single abdominal microfat (MF) injection mixed or not with PRP Low Dose (LD) or High Dose (HD) in order to improve MRI parameters and alleviate pain and enhance functional capacity in knee osteoarthritis (OA). METHODS Patients with symptomatic grade 2 to 4 knee OA according to the International Cartilage Repair Society MRI classification were selected. They were prospectively assessed at baseline, at 3 and 6 months of follow-up. The primary endpoint was the change in maximum of value of cartilage relaxation time in T2 mapping sequences (T2max) at 3 months. Secondary endpoints were MRI grade severity and joint space assessment, WOMAC score, pain evaluation, knee range of motion and patient's satisfaction. Adverse events were also collected. The complete cell counts and growth factors content of injected products were assessed to analyze their potential relationship with MRI/clinical outcomes. RESULTS Three groups of 10 patients received a single injection of 10 cc of a mix (1:1) containing either MF-Saline, MF-PRP LD or MF-PRP HD. T2max did not change significantly over the time for any of the groups. All treatments significantly improved knee functional status and symptoms relief at 3 and 6 months. All patients were responders in the MF/PRP HD at 3 months and significantly higher compared to MF/PRP LD. Half of the injected PRP in the MF/PRP LD group displayed RBCs contamination over 8% which was correlated with an impairment of T2max. CONCLUSION A single intra articular injection of MF with or without PRP is safe and may offer a significant clinical improvement in patients with OA.