RESUMEN
The objectives of this clinical trial were to evaluate the efficacy and tolerance of the Urgocell Non-Adhesive (NA) dressing in the local management of venous or mixed leg ulcers. The study was a non-comparative, prospective, multicentre (15 centres) phase III, clinical trial. The studied population was composed of non-immunodepressed adults presenting a venous or mixed leg ulcer, uninfected, non-cancerous, present for less than 18 months. Patients were followed up for 6 weeks with a weekly visit, including a clinical examination, area tracings and photographs. Evaluation by nursing staff and patients was performed at each dressing changed. Forty-three patients were included, presenting a leg ulcer with a mean surface area of 10.7 cm2. The surface area was reduced by a mean of 38% after 6 weeks of treatment. Four local adverse events were deemed to be related to the tested treatment and acceptability was noted very good for patients and nursing staff. The Urgocell NA dressing, combined with compression therapy, promoted the healing of the chronic wounds under study. The good tolerance and acceptability of the tested dressing were greatly appreciated.
Asunto(s)
Vendajes , Úlcera de la Pierna/enfermería , Anciano , Diseño de Equipo , Femenino , Humanos , Masculino , Satisfacción del Paciente , Poliuretanos/uso terapéutico , Resultado del Tratamiento , Cicatrización de HeridasRESUMEN
Ninety-eight samples from 80 cases of spontaneous abortions after fetal death or hydrops fetalis from 12,000 pregnant women were examined using PCR. DNA was extracted from amniotic fluid, fetal blood, ascitic fluid and fetal biopsies or placenta specimens using QIA amp kits (QIAGEN). A 270-bp length fragment located within the B19 gene NS1 was amplified using PCR followed by electrophoresis and southern-blot hybridization assay using a horseradish peroxidase-labelled probe and chemiluminescence detection. This assay was able to detect 1 to 10 DNA copies in a 10 microliters sample. Parvovirus B19 was identified in 11 cases (14% of fetal hydrops; 1 case for 1,100 pregnancies). Amniotic fluid was the most common and reliable sample to assess the diagnosis. Gestational age ranged from 17 to 28 weeks (mean 23 weeks). IgM antibodies were detected in 3 maternal sera, 2 patients of which reported an exposure to B19 infection during pregnancy. In 2 cases, intrauterine blood transfusions led to the cessation of symptoms and to birth of normal babies.
Asunto(s)
Hidropesía Fetal/virología , Infecciones por Parvoviridae/diagnóstico , Parvovirus B19 Humano , Complicaciones Infecciosas del Embarazo/diagnóstico , Adolescente , Adulto , Anticuerpos Antivirales/sangre , Southern Blotting , ADN Viral/aislamiento & purificación , Femenino , Humanos , Inmunoglobulina G/sangre , Inmunoglobulina M/sangre , Infecciones por Parvoviridae/etiología , Infecciones por Parvoviridae/inmunología , Parvovirus B19 Humano/genética , Parvovirus B19 Humano/inmunología , Parvovirus B19 Humano/aislamiento & purificación , Reacción en Cadena de la Polimerasa/métodos , Embarazo , Complicaciones Infecciosas del Embarazo/inmunología , Complicaciones Infecciosas del Embarazo/virología , Estudios RetrospectivosRESUMEN
Human parvovirus B19 primary infection during pregnancy is responsible for 27% of non autoimmune hydrops fetalis. Parvovirus B19 antigen detection and parvovirus B19 IgM and IgG antibody determination using enzyme immunoassays are not reliable for diagnostic purposes and lack of specificity. Parvovirus B19 DNA detection in amniotic fluid, fetal blood, ascitic fluid, and fetal biopsies or placenta specimens seems to be the best method for the diagnosis. Ninety-seven samples from 70 cases of spontaneous abortions after fetal death or hydrops fetalis were examined using PCR. A 270-bp length fragment of the NSI gene was amplified using PCR followed by electrophoresis, by Dot-blot hybridization assay using a biotinylated probe and by Southern-blot hybridization assay using a horseradish peroxidase-labelled probe followed by chemiluminescent assay. The Southern-blot hybridization assay was the longest test but the most sensitive. The parvovirus B19 genome was identified in 10 cases. In two cases, intrauterine blood transfusions led to the cessation of symptoms and to the birth of normal babies.