NCT01991834

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

1.5 years

First QC Date

November 18, 2013

Last Update Submit

April 24, 2015

Conditions

Infection Secondary to Surgical Procedure

Keywords

laparoscopysurgical wound infectionantibiotic prophylaxisgynecologic surgical procedures

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Procedure: gynecologic laparoscopyDrug: Placebo

Cefazolin

ACTIVE COMPARATOR

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

Procedure: gynecologic laparoscopyDrug: Cefazolin

Interventions

gynecologic laparoscopyPROCEDURE

Gynecological laparoscopy without opening hollow viscera.

Also known as: pelvic laparoscopy, gynecologic laparoscopic surgery
CefazolinPlacebo
CefazolinDRUG

Intravenous administration of 1 g of cefazolin

Also known as: Cephazolin, Cefazoline, Cephazolin Sodium for Injection, Kefzol
Cefazolin
PlaceboDRUG

Intravenous administration of saline sterile solution

Also known as: placebo treatment
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital das Clinicas Samuel Libanio

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

Hospital e Maternidade Santa Paula

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

CefazolinInjections

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Fabiola SM Campos, MD

    Universidade do Vale do Sapucai

    PRINCIPAL INVESTIGATOR

  • Daniela F Veiga, MD, PhD

    Universidade do Vale do Sapucai

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

April 27, 2015

Record last verified: 2015-04

Locations

BR(2)