Efficacy of autologous platelet-rich plasma for the treatment of muscle rupture with haematoma: a multicentre, randomised, double-blind, placebo-controlled clinical trial.

BACKGROUND: The goals of the treatment of muscle injuries are to shorten the time of healing and to avoid relapses. The aim of this study was to assess the efficacy of autologous platelet-rich plasma (PRP) in the healing of muscle injuries. MATERIALS AND METHODS: A multicentre, randomised, double-blind, parallel, controlled clinical trial was conducted in 71 patients (81.8% males) aged 45.6 (SD=10.0) years with muscle tears in the legs and haematoma. The haematoma was evacuated in all patients. Thirty-three patients were randomised to a single dose of autologous PRP and 38 patients to simulation of PRP administration. The primary end-point was time to complete recovery of muscle injury. Secondary end-points were pain, relapses, ultrasound parameters, and adverse events. The total follow-up per patient was 12 months. RESULTS: Time to complete recovery after the treatment was 31.63 days (SD=15.38) in the PRP group, and 38.43 days (SD=18.58) in the control group (p=0.261). Pain decreased over time in both groups without statistical differences between them. Eight patients relapsed (seven in the control group, and one in the PRP group). There were no adverse effects related to the interventions. DISCUSSION: Autologous PRP did not significantly improve the time to healing compared to that in the control group.

Nuevas perspectivas en el abordaje de la degeneración macular asociada a la edad / New perspectives in the approach to age-related macular degeneration

La aprobación de aflibercept para el tratamiento de la forma neovascular de degeneración macular asociada a la edad ha abierto la posibilidad de tratar a los pacientes con menos inyecciones dada la bimestralidad de dosificación de aflibercept, así como rescatar pacientes con respuesta subóptima a otros tratamientos antiangiogénicos. El presente manuscrito revisa la evidencia científica existente respecto al tratamiento con aflibercept, tanto en pacientes no tratados previamente como en aquellos con respuesta insatisfactoria a los tratamientos convencionales

The approval of aflibercept for the neovascular form of age-related macular degeneration has opened up the possibility of treating patients with fewer injections, since the drug can be administered once every two months. Aflibercept can also be used as rescue therapy in patients with suboptimal response to other antiangiogenic treatments. The present study reviews the scientific evidence on aflibercept, both in treatment-naïve patients and in those with an unsatisfactory response to conventional treatments

Effects of a whole body vibration (WBV) exercise intervention for institutionalized older people: a randomized, multicentre, parallel, clinical trial.

OBJECTIVES: To assess the efficacy of an exercise program on a whole-body vibration platform (WBV) in improving body balance and muscle performance and preventing falls in institutionalized elderly people. DESIGN/SETTING/PARTICIPANTS: A multicentre randomized parallel assessor-blinded clinical trial was conducted in elderly persons living in nursing homes. INTERVENTIONS: Participants were randomized to an exercise program performed either on a whole body vibratory platform (WBV plus exercise group) or on a stationary surface (exercise group). The exercise program for both groups consisted of static and dynamic exercises (balance and strength training over a 6-week training period of 3 sessions per week). The frequency applied on the vibratory platform was 30 to 35 Hz and amplitude was 2 to 4 mm. MEASUREMENTS: The primary outcome measurement was static/dynamic body balance. Secondary outcomes were muscle strength and number of falls. Efficacy was analyzed on an intention-to-treat basis and per protocol. The effects of the intervention were evaluated using the t test, Mann-Whitney test, or chi-square test, depending on the type of outcome. Follow-up measurements were collected 6 weeks and 6 months after randomization. RESULTS: A total of 159 participants from 10 centers were included: 81 in the WBV plus exercise group and 78 in the control group. Mean age was 82 years, and 67.29% were women. The Tinetti test score showed a significant overall improvement in both groups (P < .001). No significant differences were found between groups at week 6 (P = .890) or month 6 (P = .718). The Timed Up and Go test did not improve (P = .599) in either group over time, and no significant differences were found between groups at week 6 (P = .757) or month 6 (P = .959). Muscle performance results from the 5 Sit-To-Stand tests improved significantly across time (P = .001), but no statistically significant differences were found between groups at week 6 (P = .709) or month 6 (P = .841). A total of 57 falls (35.8%) were recorded during the follow-up period, with no differences between groups (P = .406). CONCLUSION: Exercise program on a vibratory platform provides benefits similar to those with exercise program on a stationary surface in relation to body balance, gait, functional mobility, and muscle strength in institutionalized elderly people. Longer studies in larger samples are needed to assess falls.

A randomized controlled trial to assess the efficacy and cost-effectiveness of urinary catheters with silver alloy coating in spinal cord injured patients: trial protocol.

BACKGROUND: Patients with non-acute spinal cord injury that carry indwelling urinary catheters have an increased risk of urinary tract infection (UTIs). Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce UTIs; however, actual evidence cannot be extrapolated to spinal cord injured patients. The aim of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of standard urinary catheters in spinal cord injured patients to prevent UTIs. METHODS/DESIGN: The study will consist in an open, randomized, multicentre, and parallel clinical trial with blinded assessment. The study will include 742 spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants will be online centrally randomized and allocated to one of the two study arms (silver alloy-coated or standard catheters). Catheters will be used for a maximum period of 30 days or removed earlier if the clinician considers it necessary. The main outcome will be the incidence of UTIs by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients. DISCUSSION: The aim of this study is to assess whether silver alloy-coated silicone urinary catheters improve ITUs in spinal cord injured patients. ESCALE is intended to be the first study to evaluate the efficacy of the silver alloy-coated catheters in spinal cord injured patients. TRIAL REGISTRATION: NCT01803919.

Guías de tratamiento del desprendimiento de retina rhegmatógeno / Rhegmatogenous retinal detachment treatment guidelines

El objetivo de esta guía es describir unas directrices generales del proceso seguido por el cirujano oftalmólogo desde el diagnóstico del desprendimiento de retina, pasando por su evaluación preoperatoria, hasta su tratamiento, complicaciones intra y postoperatorias, fracaso o recidiva del desprendimiento de retina rhegmatógeno, y las posibles alternativas terapéuticas en cada caso. También describiremos el tratamiento del desprendimiento de retina traumático por su importancia y peculiaridades. Se sugieren líneas de tratamiento o profilaxis para las diferentes situaciones del desprendimiento de retina en base a la variables encontradas, a la experiencia de los cirujanos oftalmólogos de la comisión que las ha redactado, y a la revisión bibliográfica con los distintos niveles de evidencia, pero no pretende establecer criterios de obligado cumplimiento, sobre todo considerando que el desprendimiento de retina tiene amplias posibilidades de tratamiento, y que la experiencia del cirujano en una u otra técnica va a ser fundamental en la obtención del mejor resultado quirúrgico. Como guías que son, solamente pretenden asesorar al cirujano en la práctica diaria, dejando en sus manos y en su experiencia la mejor opción terapéutica(AU)

This paper outlines general guidelines following the initial diagnosis of rhegmatogenous retinal detachment. These include preoperative evaluation, treatment, possible intra- and post-operative complications, retinal re-detachment, and all therapeutic options available for each case. Treatment of the traumatic retinal detachment is also described, due to its importance and peculiarities. Treatment or prophylactic guidelines are suggested for the different types of retinal detachment described. These are based on both the experience of the ophthalmologists that have participated in preparing the guidelines, and also on evidence-based grading linked to bibliographical sources. However, these guidelines should not be interpreted as being mandatory. Given that there is a wide spectrum of options for treatment of retinal detachment, the surgeons’ experience with one or other surgical technique will be of utmost importance in obtaining the best surgical result. As guidelines, they are intended as an additional aid to the surgeon during the decision-making process, with the expectation that the final choice will still be left to the surgeon's judgment and past experience(AU)

De la evidencia científica a la práctica clínica: pautas de tratamiento del edema macular secundario a oclusión venosa retiniana / From scientific evidence to clinical practice: treatment regimens for macular edema secondary to retinal vein occlusion

Las oclusiones venosas de la retina (OVR) son la segunda causa más frecuente de enfermedad vascular de la retina después de la retinopatía diabética. A pesar de la existencia de varias opciones terapéuticas posibles, ninguna resultó del todo satisfactoria, y muchos pacientes sufrían una pérdida visual irreversible. Como resultado de los ensayos BRAVO,CRUISE y GENEVA, ranibizumab y los implantes intravítreos biodegradables de dexametasona han sido recientemente aprobados por la Food and Drug Administration en los Estados Unidos y por la Agencia Europea del Medicamento para el tratamiento del edema macular secundario a OVR. En este trabajo comenzamos describiendo las opciones actuales de tratamiento para el edema macular secundario a oclusión venosa retiniana y continuamos con la descripción de la pauta de tratamiento con ranibizumab(AU)

Retinal vein occlusion (RVO) is the second most common cause of retinal vascular disease after diabetic retinopathy. Despite the existence of several possible treatment options, none was entirely satisfactory and many patients suffered irreversible visual loss. As a result of the BRAVO, CRUISE and GENEVA trials, ranibizumab and the intravitreal biodegradable implants of dexamethasone has recently been approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of RVO secondary edema. In this paper we begin by describing the current treatment options for RVO associated macular edema and continue with the description of the treatment regimen with ranibizumab(AU)

Low- vs. high-pressure suction drainage after total knee arthroplasty: a double-blind randomized controlled trial.

AIM: The aim of this study was to assess the efficacy of continuous low-pressure suction drainage compared with closed high-pressure suction following total knee arthroplasty. BACKGROUND: Closed wound drainage systems are used in surgical interventions to reduce the incidence of haematomas, promote wound healing and reduce infections. However, evidence shows that using a closed wound drainage system can increase transfusion requirements. DATA SOURCES: A randomized, double-blind and parallel controlled trial was performed. Adult knee replacement patients recruited between May 2006 and March 2007 were assigned to receive low-pressure suction of 50 mmHg (experimental drainage) or high-pressure suction of 700 mmHg (comparator drainage). METHODS: The primary outcome was total blood loss after surgery. Secondary outcomes were incidence of transfusion, complications and mortality. Statistical analysis was based on an intention-to-treat approach. Linear regression was performed to account for factors that could influence blood loss. RESULTS: A total of 169 patients were included. Mean age was 73 (±6) years, 128 women and 41 men. A total of 84 patients were randomized to the experimental drainage and 85 to the comparator drainage. Analysis showed a total postoperative blood loss of 541·8 mL in the experimental group and 524·4 mL in the comparator group (P = 0·734). The only factor that showed an association with blood loss was the length of surgery. Linear regression did not show differences between the groups. CONCLUSION: Continuous low-pressure suction of 50 mmHg is not more effective than the higher aspiration pressure system to diminish the blood loss in total knee arthroplasty. The results do not support any change in current nursing practice relating to the use of this drain system.

Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial.

BACKGROUND: Institutionalized older persons have a poor functional capacity. Including physical exercise in their routine activities decreases their frailty and improves their quality of life. Whole-body vibration (WBV) training is a type of exercise that seems beneficial in frail older persons to improve their functional mobility, but the evidence is inconclusive. This trial will compare the results of exercise with WBV and exercise without WBV in improving body balance, muscle performance and fall prevention in institutionalized older persons. METHODS/DESIGN: An open, multicentre and parallel randomized clinical trial with blinded assessment. 160 nursing home residents aged over 65 years and of both sexes will be identified to participate in the study. Participants will be centrally randomised and allocated to interventions (vibration or exercise group) by telephone. The vibration group will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm) over a six-week training period (3 sessions/week). The exercise group will perform the same exercise protocol but without a vibration stimuli platform. The primary outcome measure is the static/dynamic body balance. Secondary outcomes are muscle strength and, number of new falls. Follow-up measurements will be collected at 6 weeks and at 6 months after randomization. Efficacy will be analysed on an intention-to-treat (ITT) basis and 'per protocol'. The effects of the intervention will be evaluated using the "t" test, Mann-Witney test, or Chi-square test, depending on the type of outcome. The final analysis will be performed 6 weeks and 6 months after randomization. DISCUSSION: This study will help to clarify whether WBV training improves body balance, gait mobility and muscle strength in frail older persons living in nursing homes. As far as we know, this will be the first study to evaluate the efficacy of WBV for the prevention of falls. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01375790.

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review.

BACKGROUND: Autologous plasma rich in platelets (PRP) is a derived blood product whose application in clinical practice is growing. A systematic review was conducted to evaluate its efficacy and safety. STUDY DESIGN AND METHODS: A search was performed in electronic databases. Randomized controlled clinical trials (RCTs) in adult patients were included and assessed for methodologic quality. The main outcomes were "tissue regeneration" and "safety." Relative risks (RRs) and standardized mean differences (SMDs) were calculated to show pooled estimates for these outcomes. When the results heterogeneity was more than 50 percent, a sensitivity analysis was performed. RESULTS: Twenty RCTs were included (11 of oral and maxillofacial surgery, 7 of chronic skin ulcers, and 2 of surgery wounds). Four RCTs evaluated the depth reduction in gingival recession in chronic periodontitis; the SMD was 0.54 (95% confidence interval [CI], 0.16 to 0.92) mm, favorable to PRP. Three RCTs evaluated the clinical attachment level in chronic periodontitis; the SMD was 0.33 (95% CI, -0.71 to 1.37) mm. Six RCTs assessed the complete skin epithelialization in wound ulcers; the RR was 1.40 (95% CI, 0.85 to 2.31). Only 6 RCTs reported adverse effects without differences between groups. CONCLUSIONS: PRP improves the gingival recession but not the clinical attachment level in chronic periodontitis. In the complete healing process of chronic skin ulcers, the results are inconclusive. There are little data about PRP safety. There are several methodologic limitations and, consequently, future research should focus on strong and well-designed RCTs that assess the efficacy and safety of PRP.