PROPHYLACTIC ANTIBIOTICS PRIOR TO CESAREAN SECTION IN OBESE WOMEN: Does Increasing the Dose Increase the Tissue Concentration?
Cefazolin
+ Cefazolin
Poids Corporel+6
+ Troubles de la Nutrition
+ Maladies nutritionnelles et métaboliques
Étude de prévention
Résumé
Date de début de l'étude : 1 avril 2013
Date à laquelle le premier participant a commencé l'étude.Surgical site infections are common and a cause of major morbidity. They are also more common in obese women. Cesarean sections are the most common surgery performed in the United States, therefore pregnant women are being faced with this problem frequently. There is evidence to show that prophylactically administered antibiotics, cefazolin specifically, to obese women prior to cesarean section do not reach adequate concentrations in adipose tissue to prevent infection. The purpose of this study is to evaluate if an increased dose of cefazolin will attain adequate tissue concentration in obese women. Our hypothesis is that three grams of cefazolin given no more than 60 minutes prior to the start of a cesarean section in an obese (Body mass index (BMI) greater than or equal to 30) woman will attain adequate adipose tissue concentration compared to two grams of cefazolin. Subjects will be selected if they are greater than 37 weeks gestation wiht a singleton pregnancy and require a cesarean section for any obstetrical indication. Women will be excluded if they have a suspected infection, have a multiple gestation, or have preexisting diabetes or hypertension with end organ damage. The subjects will be screened both by through the OR schedule as well as through the clinics. They will then be consented and enrolled by the primary investigator. Once enrolled the subjects will be randomized to receive either two grams or three grams of cefazolin as prophylactic antibiotics to be given no more than 60 minutes prior to the start of the surgery. Two adipose tissue samples will be obtained at the time of surgery. The first at the start after skin incision and the second at the end prior to closure of the skin. There will also be a separate IV placed at the start of the procedure from which three blood draws can be collected. These three samples will be obtained at the start of the surgery but after antibiotic administration, at the time of the first adipose collection, and at the time of the second adipose collection. The samples will then be stored at -80 degrees and shipped to David P. Nicolau's lab in Hartford, CT for the tissue and serum analysis. While the subjects are in the hospital recovering from their surgery, a chart review will be performed to determine if there are any infections occuring post-operatively. A telephone survey will be conducted six to eight weeks postpartum again assessing for any infectious complications after the cesarean section.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.58 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Women & Infants Hospital
Providence, United StatesOuvrir Women & Infants Hospital dans Google Maps