RESUMO
The objective of this study was to evaluate in a sheep model the performance of a new polypropylene mesh (TVTx), which is intended as a less invasive treatment for female stress urinary incontinence. Eight female sheep were used in this study, each one being implanted with eight TVTx samples. At each time-point (weeks 1, 2, 4, and 12) seven TVTx were pulled out, while one TVTx was carefully dissected for histological investigations. One TVTx and one TVT, moreover, were inserted and immediately pulled out for obtaining the initial pullout forces in all sheep. The initial pullout values of TVT and TVTx were overlapping. The pullout forces of TVTx were >5 N (500 g) and increasing from weeks 1 to 12 (p<0.001). Histology revealed good tissue integration of TVTx in the tissue within 12 weeks after implantation. No abnormal histological findings were observed. This data could support the realization of a clinical trial with the TVTx mesh.
Assuntos
Materiais Biocompatíveis , Slings Suburetrais , Incontinência Urinária por Estresse/cirurgia , Animais , Materiais Biocompatíveis/efeitos adversos , Feminino , Teste de Materiais , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Modelos Animais , Polipropilenos , Desenho de Prótese , Ovinos , Slings Suburetrais/efeitos adversos , Fatores de TempoRESUMO
PURPOSE: To evaluate the equivalency of the prototype of a new infrared ear thermometer (IRT 4000) in comparison to the temperature measurements of a pulmonary artery catheter (PAC) and a continual contact probe on the tympanic membrane. METHODS: After approval by the local Ethics Committee, 26 (six female and 20 male) patients undergoing elective cardiac surgery were included in a single center open trial. During surgery, temperature measurements were recorded with the IRT 4000 in the left ear, and with a tympanic contact probe in the right ear, as well as with a PAC as reference. Measurements with the infrared ear thermometers and continual PAC values were recorded every six minutes. RESULTS: The average temperature measured with the IRT 4000 was 0.08 degrees C above the temperature of the PAC (95% confidence interval from -0.44-0.61 degrees C). CONCLUSION: Infrared ear thermometers 4000 temperature readings accurately reflect body core temperature and correlate well with the invasive PAC. Infrared ear thermometers may present a clinically useful alternative to the pulmonary artery thermometry for the measurement of core temperature in the perioperative setting or in the intensive care unit.
