Trial | NCT01991834  Report issue

Official Title

Antibiotic Prophylaxis in Gynecologic Laparoscopy

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cefazolin ...

  • Study Participants

    114
Laparoscopy is a surgical procedure indicated for most gynecological pathologies and presents numerous advantages over laparotomy, among them lower rates of surgical site infection and less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is widely accepted and performed by most gynecologists. However, there isn't literature evidence to support the routine use of antibiotics in the prophylaxis of wound infection on laparoscopic pelvic surgery .Therefore, this study will evaluate the need for the use of antibiotic prophylaxis in gynecological laparoscopies not including opening hollow viscera.
It is a clinical, prospective, double-blind, randomized study. 114 women with gynecologic disease, in which there is indication of laparoscopic surgical approach, will be consecutively select. These women will be allocated in two arms, control and study, where control group will use placebo and study will receive intravenous cephazolin. These patients will be followed for 30 days according to Centers for Disease Control and Prevention criteria.
Study Started
Sep 30
2013
Primary Completion
Mar 31
2015
Study Completion
Apr 30
2015
Last Update
Apr 27
2015
Estimate

Drug Cefazolin

Intravenous administration of 1 g of cefazolin

  • Other names: Cephazolin, Cefazoline, Cephazolin Sodium for Injection, Kefzol

Drug Placebo

Intravenous administration of saline sterile solution

  • Other names: placebo treatment

Procedure gynecologic laparoscopy

Gynecological laparoscopy without opening hollow viscera.

  • Other names: pelvic laparoscopy, gynecologic laparoscopic surgery

Placebo Placebo Comparator

Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy.

Cefazolin Active Comparator

Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy.

Criteria 

Inclusion Criteria:

patients with gynecologic disease, undergoing gynecologic laparoscopy without opening hollow viscera.

Exclusion Criteria:

body mass index over 30 Kg/m2
smoking
diabetes type I or II with glycated hemoglobin exceeding 6.5%
patients who are at surgical risk classification of the American Society of Anesthesiologists(ASA) as ASA III or higher
refusal to participate
postoperative antibiotic therapy for another indication clinical complication
No Results Posted