Infection Secondary to Surgical ProcedureNCT01991834
Antibiotic Prophylaxis in Gynecologic Laparoscopy
A study testing gynecologic laparoscopy and Cefazolin in people with Infection Secondary to Surgical Procedure, run by Universidade do Vale do Sapucai at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Infection Secondary to Surgical Procedure
- What is being tested?
- gynecologic laparoscopy and Cefazolin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 2 sitesBrazil
- Study dates
- Sep 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with gynecologic disease, undergoing gynecologic laparoscopy without opening hollow viscera.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital das Clinicas Samuel Libanio
Pouso Alegre, Minas Gerais, 37550-000
Hospital e Maternidade Santa Paula
Pouso Alegre, Minas Gerais, 37550-000
About this study
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.
Read the 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.
- Being tested
- gynecologic laparoscopy, Cefazolin, Placebo
- Keywords
- laparoscopy, surgical wound infection, antibiotic prophylaxis, gynecologic surgical procedures
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gynecologic laparoscopyProcedure or surgery
Also called pelvic laparoscopy, gynecologic laparoscopic surgery
Gynecological laparoscopy without opening hollow viscera.
CefazolinDrug
Also called Cephazolin, Cefazoline, Cephazolin Sodium for Injection, Kefzol
Intravenous administration of 1 g of cefazolin
PlaceboDrug
Also called placebo treatment
Intravenous administration of saline sterile solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy. Receives: Procedure: gynecologic laparoscopy; Drug: Placebo |
| Cefazolin | Active comparator | Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy. Receives: Procedure: gynecologic laparoscopy; Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Secondary to Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiola Soares Moreira Campos, Universidade do Vale do Sapucai
- Investigators
- Fabiola SM Campos, MD, Principal investigator, Universidade do Vale do SapucaiDaniela F Veiga, MD, PhD, Study chair, Universidade do Vale do Sapucai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991834
- Sponsor's protocol ID
- MPFabiola
- Status last verified
- Apr 2015
- First submitted
- 18 Nov 2013
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in Gynecologic Laparoscopy
- ClinicalTrials.gov ID
- NCT01991834
- Acronym / sponsor ID
- MPFabiola
- Keywords
- laparoscopy, surgical wound infection, antibiotic prophylaxis, gynecologic surgical procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Procedure: gynecologic laparoscopy, Drug: PlaceboPatients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy. |
| Cefazolin | Active comparator | Procedure: gynecologic laparoscopy, Drug: CefazolinPatients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with gynecologic disease, undergoing gynecologic laparoscopy without opening hollow viscera.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gynecologic laparoscopyAlso: pelvic laparoscopy, gynecologic laparoscopic surgeryGynecological laparoscopy without opening hollow viscera. | Procedure or surgery | Cefazolin, Placebo |
| CefazolinAlso: Cephazolin, Cefazoline, Cephazolin Sodium for Injection, KefzolIntravenous administration of 1 g of cefazolin | Drug | Cefazolin |
| PlaceboAlso: placebo treatmentIntravenous administration of saline sterile solution | Drug | Placebo |
Primary outcome
Surgical site infection
Time frame: 30 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabiola SM Campos, MD principal investigator
Universidade do Vale do Sapucai
Daniela F Veiga, MD, PhD study chair
Universidade do Vale do Sapucai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gynecologic laparoscopy and Cefazolin in people with Infection Secondary to Surgical Procedure, run by Universidade do Vale do Sapucai at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.