RESUMEN
PURPOSE: A totally implantable vascular access port (TIVAP) is commonly required in cancer patients. Possible adverse events after TIVAP implantation include surgical site infection (SSI) and port-related bacteremia. This study examined whether adhesive surgical drapes can reduce the risk of SSI. METHODS: A total of 100 mostly cancer patients were randomized into two groups before undergoing TIVAP implantation by surgical cut-down. In one group, an adhesive, non-impregnated drape was applied to the skin prior to incision, while the control group underwent surgery without a drape. Swabs were taken from the surgical site and sent for microbiologic testing. SSI rates were compared between groups. RESULTS: No SSI occurred within 30 days after surgery. In each group, two patients died. There were 5 complications (port thrombosis, port dislocation, two cases of pneumothorax, skin allergy), all in the intervention group (p = 0.056). Using the incision drape prolonged procedure time by + 5 min (95% CI - 1 to + 10, p = 0.125). Microbiologic swab testing failed to detect any effect of the incision drape. CONCLUSIONS: Plastic adhesive skin drapes may be unnecessary in cancer patients who undergo surgical implantation of a TIVAP.
Asunto(s)
Neoplasias , Paños Quirúrgicos , Dispositivos de Acceso Vascular , Adhesivos , Humanos , Proyectos Piloto , Plásticos , Paños Quirúrgicos/efectos adversos , Infección de la Herida Quirúrgica/etiología , Infección de la Herida Quirúrgica/prevención & control , Dispositivos de Acceso Vascular/efectos adversosRESUMEN
BACKGROUND: This prospective, clinical, randomized, double-blind study was intended to investigate the impact of the structure and the amount of polypropylene (PP) mesh used in laparoscopic transabdominal preperitoneal hernioplastic (TAPP) on physical function and life quality. METHODS: 180 male patients with primary inguinal hernia undergoing TAPP were randomized for using a heavyweight (108 g/m(2)), double-filament PP mesh (Prolene, 10 x 15 cm, group A, n = 60), a multifilament, heavyweight variant (116 g/m(2)) of PP mesh (Serapren, 10 x 15 cm, group B, n = 60), or a composite mesh (polyglactin and PP) (Vypro II, 10 x 15 cm, group C, n = 60). We compared in terms of complications (seromas, recurrence rate) and life quality (pain development, physical function). The development of life quality was documented according to the SF-36 Health Survey. The follow-up period was 60 months. RESULTS: The recurrence rate (2.2% overall) during 60-month follow-up was not significantly different between the groups. Convalescence in group A was slower than in groups B and C: mean-term values of the visual scales for pain development were significantly (p < 0.05) higher, incapacity for work was 8.2 days longer, and urological adverse effects were stronger. The mean-term development of life quality was significantly lower in group A up to 12th week postoperatively. There were no significant differences between groups B and C. Beyond the 12th postinterventional week the differences diminished. CONCLUSIONS: The composite mesh does not provide an advantage concerning physical function or pain development in comparison to the multifilament, heavyweight, pure polypropylene mesh. Independently of which mesh was implanted 5% of patients are still suffering from discomfort after 5 years.