- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00610987
Antibiotic Prophylaxis in Orthopaedic Traumatology
Antibiotic Prophylaxis in Orthopaedic Traumatology: A Prospective, Randomized Trial of Duration of Administration
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The proposed study is a prospective, randomized, double-blinded clinical trial intended to further define the appropriate duration of antibiotic (cefazolin) administration for surgical prophylaxis in the internal fixation of closed fractures. Our hypothesis is that there will be no difference in the incidence of infection between single-dose versus 24 hours of antibiotic prophylaxis. The null hypothesis is that multiple-dose antibiotic prophylaxis will have a decreased incidence of infection.
Research Design:
A prospective, randomized, double-blinded clinical trial will be conducted to evaluate the duration of antibiotic prophylaxis. After investigators obtain Institutional Review Board approval, recruited patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. If a tourniquet is used, the cefazolin will be administered at least 10 minutes prior to inflation. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours. Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo. Group assignments will not be disclosed to the evaluators responsible for clinical examination or to the patients until the end of the study.
Either an orthopaedic surgeon or nurse practitioner will evaluate the patients for the development of a wound infection. Follow-up will occur at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs. Wound infection will be defined as one or more of the classic signs and symptoms of inflammation (rubor, calor, tumor, dolor) together with purulent drainage at the operative site. Wound infections will be classified either as superficial (infection of the skin or subcutaneous tissue, not communicating with the bone) or deep (infection that reached bone or material implanted for osteosynthesis). Bacteriological cultures will be obtained in the event of infectious complications, but wound infections will be diagnosed clinically.
Several studies have demonstrated that there are numerous patient-related and treatment-related factors that predispose to infectious complications. We will use several of these factors to assign a risk score to each of the enrolled patients. Each factor will be worth one point for a total score ranging from 0 (lowest risk) to 7 (highest risk). The risk factors are: 1) smoking; 2) age >65; 3) diabetes mellitus; 4) obesity (BMI >35); 5) duration of surgery >3 hours; 6) urinary catheterization (0=no catheter, 1=catheter <48 hours, 2=catheter >48 hours).
Statistical evaluation will be conducted by Student's t-test for patient characteristics and chi square analysis for infection rates. The relation between wound infection and the various possible risk factors will be assessed by forward stepwise logistic regression analysis. Significance will be defined at the P < 0.05 level.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Missouri
-
Columbia, Missouri, Estados Unidos, 65212
- University of Missouri
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients 18 years or older;
- Scheduled for primary osteosynthesis or placement of a prosthetic device in the treatment of closed limb fractures;
- Ability to give informed consent.
Exclusion Criteria:
- Known hypersensitivity to cephalosporins;
- Antimicrobial use or symptoms of infection in the week before surgery;
- Pregnancy;
- Immunosuppressive treatment;
- Inability to give informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Cefazolin
Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.
|
Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution.
A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg.
A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room.
Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours.
Otros nombres:
|
Comparador de placebos: Placebo
Group II will receive no additional antibiotic.
Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin
|
Patients will be randomly assigned to one of two groups.
Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution.
A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg.
A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room.
Upon completion of the surgical procedure, Group II will receive no additional antibiotic.
Instead, they will receive normal saline injection every eight hours as a placebo.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants With Total Wound Infections
Periodo de tiempo: at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs.
|
The primary endpoint was infection.
|
at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB1089017
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Heridas y Lesiones
-
Bambino Gesù Hospital and Research InstituteTerminadoObesidad Pediátrica Severa (IMC > 97° pc -Según Centers for Disease Control and Prevention IMC Charts-) | Pruebas de función hepática alterada | Intolerancia glucémicaItalia
Ensayos clínicos sobre cefazolin
-
University of California, Los AngelesAún no reclutandoHerida que no cicatriza
-
B. Braun Medical Inc.Terminado