Antibiotic Prophylaxis in Gynecologic Laparoscopy
Information source: Universidade do Vale do Sapucai
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection Secondary to Surgical Procedure
Intervention: gynecologic laparoscopy (Procedure); Cefazolin (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Universidade do Vale do Sapucai Official(s) and/or principal investigator(s): Fabiola SM Campos, MD, Principal Investigator, Affiliation: Universidade do Vale do Sapucai Daniela F Veiga, MD, PhD, Study Chair, Affiliation: Universidade do Vale do Sapucai
Summary
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.
Clinical Details
Official title: Antibiotic Prophylaxis in Gynecologic Laparoscopy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Surgical site infection
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
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
Locations and Contacts
Hospital das Clinicas Samuel Libanio, Pouso Alegre, Minas Gerais 37550-000, Brazil
Hospital e Maternidade Santa Paula, Pouso Alegre, Minas Gerais 37550-000, Brazil
Additional Information
Starting date: September 2013
Last updated: April 24, 2015
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