Antibiotic Prophylaxis in Gynecologic Laparoscopy

Infection Secondary to Surgical Procedure Clinical Trial

Official title:

Antibiotic Prophylaxis in Gynecologic Laparoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991834
• Other study ID #: MPFabiola
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: April 24, 2015
• Start date: September 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection Secondary to Surgical Procedure

Intervention

Procedure:
• gynecologic laparoscopy
Gynecological laparoscopy without opening hollow viscera.

Drug:
• Cefazolin
Intravenous administration of 1 g of cefazolin
• Placebo
Intravenous administration of saline sterile solution

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas Samuel Libanio	Pouso Alegre	Minas Gerais
Brazil	Hospital e Maternidade Santa Paula	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Patients are followed weekly by a masked surgeon in regard to surgical site infecton (SSI), until the 30th postoperative day. Centers for Disease Control and Prevention's (CDC) criteria and classification were adopted.	30 days	No