Surgical InfectionPhase 3NCT01558986
Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
A Phase 3 study testing Cefazolin and Sterile water in people with Surgical Infection, run by University of the Philippines at 1 site in Philippines.
Trial summary
This is a randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Surgical Infection
- What is being tested?
- Cefazolin and Sterile water
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 sitePhilippines
- Study dates
- Dec 2007to Sep 2011
- Phase
- Phase 3
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with histologically diagnosed breast cancer of age group 18-80 years old, ECOG 0-1, clinical stage I to IIIB, admitted to the surgery ward, who were scheduled for elective MRM.
Who cannot join
- Women with significant co-morbid factors (diabetes mellitus, severe malnutrition, corticosteroid therapy), those scheduled for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week prior to surgery, with known allergy to cephalosporins, and those with local infection.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine General Hospital - University of the Philippines Manila
Manila, 1000
About this study
Official title: A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
This is a randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.
Read the detailed description
A randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.
Women with breast cancer who will undergo elective MRM were recruited for the study. Excluded were patients with significant co-morbid factors, for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week, with known allergy to cephalosporins, and those with local infection. Patients were randomized to receive either transvenous cefazolin 1 gram or sterile water only within 30 minutes prior to skin incision. Standard skin preparation and operative technique for MRM were carried out. Wounds were assessed for the presence of SSI and other complications weekly for 30 days.
- Conditions
- Surgical Infection
- Being tested
- Cefazolin, Sterile water
- Keywords
- Antibiotic prophylaxis, surgical site infection, modified radical mastectomy, Prevention of surgical site infection (SSI) in patients undergoing MRM for breast cancer
- 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.
CefazolinProcedure or surgery
Patients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision;
Sterile waterProcedure or surgery
Patients received sterile water only within 30 minutes prior to skin incision
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | Patients to receive intravenous cefazolin 1 gram within 30 minutes prior to skin incision Receives: Procedure: Cefazolin |
| Placebo Arm | Placebo comparator | Patients to receive sterile water only within 30 minutes prior to skin incision Receives: Procedure: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (as defined by the Centers for Disease Control and Prevention)
Mastectomy wounds were evaluated for the presence of SSI as defined by the Center for Disease Control and Prevention meeting the following criteria: infection that occurred within 30 days after the operative procedure and at least one of the following:
- purulent drainage (culture documentation not required)
- organism isolated from fluid/tissue of incision site
- at least one sign of inflammation (erythema, local warmth of wound, induration)
- wound is deliberately opened by the surgeon
- physician declares the wound infected
Measured: Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startDec 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelson C Cabaluna, Doctor of Medicine, Principal investigator, University of the Philippines Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558986
- Sponsor's protocol ID
- NIH 2007-07-10-02
- Status last verified
- Mar 2012
- First submitted
- 15 Mar 2012
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cabaluna ND, Uy GB, Galicia RM, Cortez SC, Yray MD, Buckley BS. A randomized, double-blinded placebo-controlled clinical trial of the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy. World J Surg. 2013 Jan;37(1):59-66. doi: 10.1007/s00268-012-1816-5.
PubMed 23052809
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT01558986
- Acronym / sponsor ID
- NIH 2007-07-10-02
- Conditions
- Surgical Infection
- Keywords
- Antibiotic prophylaxis, surgical site infection, modified radical mastectomy, Prevention of surgical site infection (SSI) in patients undergoing MRM for breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Mar 2012 (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.
This is a randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.
Detailed description
A randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.
Women with breast cancer who will undergo elective MRM were recruited for the study. Excluded were patients with significant co-morbid factors, for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week, with known allergy to cephalosporins, and those with local infection. Patients were randomized to receive either transvenous cefazolin 1 gram or sterile water only within 30 minutes prior to skin incision. Standard skin preparation and operative technique for MRM were carried out. Wounds were assessed for the presence of SSI and other complications weekly for 30 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Procedure: CefazolinPatients to receive intravenous cefazolin 1 gram within 30 minutes prior to skin incision |
| Placebo Arm | Placebo comparator | Procedure: Sterile waterPatients to receive sterile water only within 30 minutes prior to skin incision |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with histologically diagnosed breast cancer of age group 18-80 years old, ECOG 0-1, clinical stage I to IIIB, admitted to the surgery ward, who were scheduled for elective MRM.
Key exclusion criteria (1 listed)
- Women with significant co-morbid factors (diabetes mellitus, severe malnutrition, corticosteroid therapy), those scheduled for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week prior to surgery, with known allergy to cephalosporins, and those with local infection.
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 |
|---|---|---|
| CefazolinPatients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision; | Procedure or surgery | Treatment Arm |
| Sterile waterPatients received sterile water only within 30 minutes prior to skin incision | Procedure or surgery | Placebo Arm |
Primary outcome
Surgical Site Infection (as defined by the Centers for Disease Control and Prevention)
Time frame: Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days
Mastectomy wounds were evaluated for the presence of SSI as defined by the Center for Disease Control and Prevention meeting the following criteria: infection that occurred within 30 days after the operative procedure and at least one of the following: 1. purulent drainage (culture documentation not required) 2. organism isolated from fluid/tissue of incision site 3. at least one sign of inflammation (erythema, local warmth of wound, induration) 4. wound is deliberately opened by the surgeon 5. physician declares the wound infected
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 20 Mar 2012.
- Derived from this study: PubMed 23052809Cabaluna ND, Uy GB, Galicia RM, Cortez SC, Yray MD, Buckley BS. A randomized, double-blinded placebo-controlled clinical trial of the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy. World J Surg. 2013 Jan;37(1):59-66. doi: 10.1007/s00268-012-1816-5.
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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.
Nelson C Cabaluna, Doctor of Medicine principal investigator
University of the Philippines Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefazolin and Sterile water in people with Surgical Infection, run by University of the Philippines at 1 site in Philippines.
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 1 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 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (as defined by the Centers for Disease Control and Prevention) (time frame: Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01558986, which also lists 1 linked publication.
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 20 Mar 2012.