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Trials ; 20(1): 390, 2019 Jul 02.
Artículo en Inglés | MEDLINE | ID: mdl-31266520

RESUMEN

BACKGROUND: Surgical site infections (SSI) remain one of the most common complications in conventional abdominal surgery with an incidence between 4% and 19% (Sandini et al., Medicine (Baltimore) 95:e4057, 2016) in the literature. It is unclear whether the use of coated suture material for skin closure reduces the risk of SSI. In line with in-vitro results, we hypothesize that the use of antibacterial skin sutures (triclosan-coated poliglecaprone 25) reduces the rate of SSI after open abdominal surgery. METHODS/DESIGN: To prevent SSI, triclosan-coated poliglecaprone 25 sutures will be tested against un-coated suture material for skin closure after elective open abdominal surgery of 364 patients. The study is planned as a single-center, prospective randomized controlled trial. Patients will be followed for 30 days after surgery to detect and document wound complications. The rate of SSI after 30 days will be analyzed in both groups. DISCUSSION: If we can confirm the proposed hypothesis in our study, this could be a promising and feasible approach to lower SSI after open abdominal surgery. By lowering the rate of SSI this might offer a cost-saving and morbidity-reducing procedure. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00010047 . Registered on 05.01.2017.


Asunto(s)
Abdomen/cirugía , Antiinfecciosos Locales/uso terapéutico , Materiales Biocompatibles Revestidos , Infección de la Herida Quirúrgica/prevención & control , Técnicas de Sutura/instrumentación , Suturas , Triclosán/uso terapéutico , Antiinfecciosos Locales/efectos adversos , Procedimientos Quirúrgicos Electivos , Femenino , Alemania , Humanos , Masculino , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Infección de la Herida Quirúrgica/microbiología , Técnicas de Sutura/efectos adversos , Suturas/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Triclosán/efectos adversos
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