Bacterial InfectionPhase 4NCT01244698
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
A Phase 4 study testing Cefadroxil discontinued early and Cefadroxil until drain removal in people with Bacterial Infection and Anti-infective Agents, run by Stony Brook University at 1 site in United States.
Trial summary
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infection, Anti-infective Agents, Breast Implantation
- What is being tested?
- Cefadroxil discontinued early and Cefadroxil until drain removal
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to May 2014
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients presenting to Stony Brook University Medical Center Plastic Surgery clinic for immediate breast reconstruction using a tissue expander.
- Age 18 years or older
Who cannot join
- Delayed or revision implant reconstruction
- Refusal or inability to consent
- Contraindications to surgery as determined by attending physician
- Contraindications to both penicillin/cephalosporin and clindamycin antibiotics (significant allergies)
- Patients with serious existing systemic infection, defined as 2 or more of the following:
- Peripheral body temperature >38 degrees Celsius CRP >5g/L Leukocytes > 12,000/microliter
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Medical Center
Stony Brook, New York, 11792
About this study
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction.
The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
Read the detailed description
Background:
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution because drains may serve as an open channel to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains.
Current plastic surgery literature does not provide recommendations or consensus for antibiotic discontinuation following immediate breast reconstruction. A recent survey conducted of 650 plastic surgeons showed that 98% of respondents give preoperative antibiotics, while 91% provide antibiotics for up to 24 hours. Additionally, 71% of respondents prescribe postoperative outpatient antibiotics. There was a divide of when to discontinue antibiotics among plastic surgeons who gave them postoperatively. 46% preferred to continue antibiotics until drain removal, while 52% preferred a specific postoperative day, most commonly day 5 or 7.
In the same survey, the majority (97%) of surgeons use IV Cefazolin as the choice for preoperative prophylaxis and oral Cephalexin (75.4%) and Cefadroxil (14.3%) for outpatient antibiotics. Currently at Stony Brook University Medical Center, patients normally receive 24 hours of IV Cefazolin, followed by postoperative antibiotic prescription for Cefadroxil. Antibiotics are discontinued when the final drain is removed.
The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators will randomize these patients into two groups. One group will receive the current antibiotic regimen of 24 hours of IV Cefazolin, followed by outpatient Cefadroxil. Antibiotics will be discontinued for this group once the final drain is removed. The other group will only receive 24 hours of IV Cefazolin without any additional outpatient antibiotics, as is recommended for elective clean surgeries. In patients with penicillin allergies or sensitivity, clindamycin, IV and oral is used. The same randomization will apply in these patients.
Rationale for early discontinuation of postoperative antibiotics:
Studies have associated prolonged antimicrobial prophylaxis with development of resistant bacterial strains following surgical procedures. No evidence has been reported supporting practices of continuing antibiotics until drains are removed. A single dose of preoperative IV antibiotics has been suggested to be sufficient prophylaxis for most breast surgery patients discharged home with drains.
- Being tested
- Cefadroxil discontinued early, Cefadroxil until drain removal
- Keywords
- Surgical Site Infection, Breast Reconstruction, Antibiotics
- Medical subject headings
- Bacterial Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefadroxil discontinued earlyDrug
Also called Clindamycin, Cleocin, Duricef, Ancef
All patients will receive 24 hours of IV Cefazolin (1g IV every 8 hr), as is universal practice for clean breast surgery. The interventional group will then discontinue antibiotics. Clindamycin IV 600mg every 6 hours for 24 hours will be used in penicillin allergic patients.
Cefadroxil until drain removalDrug
Also called Duricef, Cefazolin, Ancef, Clindamycin
All patients will receive 24 hours of IV Cefazolin, as is universal practice for clean breast surgery. The control group will receive oral outpatient Cefadroxil (500mg 2 times a day) until the final drain is removed. This is the normal postoperative regimen. In case of significant penicillin allergy (defined as a history of urticaria or anaphylaxis associated with penicillin) patients will receive Clindamycin 600mg IV every 6 hours for 24 hours followed by clindamycin 300mg IV every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics until Drain Removal | Other | All patients will receive 24 hours of IV Cefazolin, as is universal practice for clean breast surgery. The control group will receive oral outpatient Cefadroxil until the final drain is removed. In case of significant penicillin allergy (defined as a history of urticaria or anaphylaxis associated with penicillin) patients will receive Clindamycin. Receives: Drug: Cefadroxil until drain removal |
| Early discontinuation of antibiotics | Experimental | All patients will receive 24 hours of IV Cefazolin, as is universal practice for clean breast surgery. The interventional group will then discontinue antibiotics. Receives: Drug: Cefadroxil discontinued early |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site infection
One or more of the following:
- Purulent drainage, with or without laboratory confirmation, from the superficial incision.
- Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.
- At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative.
- Diagnosis of superficial incisional SSI by the surgeon or attending physician.
Measured: 365 days after the procedure
Secondary outcomes (5)
Antibiotic Sensitivity
Assessed by documentation of an allergic or adverse sensitivity reaction including, but not limited to urticaria, itching, rash, anaphylaxis
Measured: From administration of the antibiotic until discontinuation
Clostridium Difficile Colitis
- Difficile colitis will be assessed by documented positive c. difficile toxin assay.
Measured: up to 365 days postoperatively
Antibiotic Resistance
Local wound infections will be cultured and sent for identification and susceptibility. Alternatively, pathological fluid collections will be aspirated and fluid will be sent for culture and susceptibility. Resistant strains will be documented and treated with alternative antibiotics.
Measured: 1 year postoperatively
Patient compliance
patients will be asked to bring antibiotics to clinic for counting to assess compliance.
Measured: while antibiotics are being administered postoperatively
Cost
Cost will be assessed by multiplying the duration of outpatient postoperative antibiotics by the cost for self-pay prescriptions.
Measured: while antibiotics are being administered postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2014
- Study completionMay 2014
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 Bacterial 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- The Plastic Surgery Foundation
- Responsible party
- Principal investigator, Duc T Bui, MD, Stony Brook University
- Investigators
- Duc T Bui, MD, Principal investigator, Stony Brook University Medical CenterBrett T Phillips, MD, Study director, Stony Brook University Medical CenterDuc T Bui, MD, Study chair, Stony Brook University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244698
- Sponsor's protocol ID
- 160583-3
- Status last verified
- May 2014
- First submitted
- 18 Nov 2010
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Phillips BT, Fourman MS, Bishawi M, Zegers M, O'Hea BJ, Ganz JC, Huston TL, Dagum AB, Khan SU, Bui DT. Are Prophylactic Postoperative Antibiotics Necessary for Immediate Breast Reconstruction? Results of a Prospective Randomized Clinical Trial. J Am Coll Surg. 2016 Jun;222(6):1116-24. doi: 10.1016/j.jamcollsurg.2016.02.018. Epub 2016 Mar 4.
PubMed 27106640
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
- ClinicalTrials.gov ID
- NCT01244698
- Acronym / sponsor ID
- 160583-3
- Keywords
- Surgical Site Infection, Breast Reconstruction, Antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- The Plastic Surgery Foundation
- Study start
- Nov 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Nov 2010 (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.
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction.
The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
Detailed description
Background:
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution because drains may serve as an open channel to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains.
Current plastic surgery literature does not provide recommendations or consensus for antibiotic discontinuation following immediate breast reconstruction. A recent survey conducted of 650 plastic surgeons showed that 98% of respondents give preoperative antibiotics, while 91% provide antibiotics for up to 24 hours. Additionally, 71% of respondents prescribe postoperative outpatient antibiotics. There was a divide of when to discontinue antibiotics among plastic surgeons who gave them postoperatively. 46% preferred to continue antibiotics until drain removal, while 52% preferred a specific postoperative day, most commonly day 5 or 7.
In the same survey, the majority (97%) of surgeons use IV Cefazolin as the choice for preoperative prophylaxis and oral Cephalexin (75.4%) and Cefadroxil (14.3%) for outpatient antibiotics. Currently at Stony Brook University Medical Center, patients normally receive 24 hours of IV Cefazolin, followed by postoperative antibiotic prescription for Cefadroxil. Antibiotics are discontinued when the final drain is removed.
The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators will randomize these patients into two groups. One group will receive the current antibiotic regimen of 24 hours of IV Cefazolin, followed by outpatient Cefadroxil. Antibiotics will be discontinued for this group once the final drain is removed. The other group will only receive 24 hours of IV Cefazolin without any additional outpatient antibiotics, as is recommended for elective clean surgeries. In patients with penicillin allergies or sensitivity, clindamycin, IV and oral is used. The same randomization will apply in these patients.
Rationale for early discontinuation of postoperative antibiotics:
Studies have associated prolonged antimicrobial prophylaxis with development of resistant bacterial strains following surgical procedures. No evidence has been reported supporting practices of continuing antibiotics until drains are removed. A single dose of preoperative IV antibiotics has been suggested to be sufficient prophylaxis for most breast surgery patients discharged home with drains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics until Drain Removal | Other | Drug: Cefadroxil until drain removalAll patients will receive 24 hours of IV Cefazolin, as is universal practice for clean breast surgery. The control group will receive oral outpatient Cefadroxil until the final drain is removed. In case of significant penicillin allergy (defined as a history of urticaria or anaphylaxis associated with penicillin) patients will receive Clindamycin. |
| Early discontinuation of antibiotics | Experimental | Drug: Cefadroxil discontinued earlyAll patients will receive 24 hours of IV Cefazolin, as is universal practice for clean breast surgery. The interventional group will then discontinue antibiotics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients presenting to Stony Brook University Medical Center Plastic Surgery clinic for immediate breast reconstruction using a tissue expander.
- Age 18 years or older
Key exclusion criteria (6 listed)
- Delayed or revision implant reconstruction
- Refusal or inability to consent
- Contraindications to surgery as determined by attending physician
- Contraindications to both penicillin/cephalosporin and clindamycin antibiotics (significant allergies)
- Patients with serious existing systemic infection, defined as 2 or more of the following:
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 |
|---|---|---|
| Cefadroxil discontinued earlyAlso: Clindamycin, Cleocin, Duricef, AncefAll patients will receive 24 hours of IV Cefazolin (1g IV every 8 hr), as is universal practice for clean breast surgery. The interventional group will then discontinue antibiotics. Clindamycin IV 600mg every 6 hours for 24 hours will be used in penicillin allergic patients. | Drug | Early discontinuation of antibiotics |
| Cefadroxil until drain removalAlso: Duricef, Cefazolin, Ancef, ClindamycinAll patients will receive 24 hours of IV Cefazolin, as is universal practice for clean breast surgery. The control group will receive oral outpatient Cefadroxil (500mg 2 times a day) until the final drain is removed. This is the normal postoperative regimen. In case of significant penicillin allergy (defined as a history of urticaria or anaphylaxis associated with penicillin) patients will receive Clindamycin 600mg IV every 6 hours for 24 hours followed by clindamycin 300mg IV every 6 hours. | Drug | Antibiotics until Drain Removal |
Primary outcome
Surgical Site infection
Time frame: 365 days after the procedure
One or more of the following: 1. Purulent drainage, with or without laboratory confirmation, from the superficial incision. 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision. 3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative. 4. Diagnosis of superficial incisional SSI by the surgeon or attending physician.
5 secondary outcomes
Antibiotic Sensitivity
Time frame: From administration of the antibiotic until discontinuation
Clostridium Difficile Colitis
Time frame: up to 365 days postoperatively
Antibiotic Resistance
Time frame: 1 year postoperatively
Patient compliance
Time frame: while antibiotics are being administered postoperatively
Cost
Time frame: while antibiotics are being administered postoperatively
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 13 May 2014.
- Derived from this study: PubMed 27106640Phillips BT, Fourman MS, Bishawi M, Zegers M, O'Hea BJ, Ganz JC, Huston TL, Dagum AB, Khan SU, Bui DT. Are Prophylactic Postoperative Antibiotics Necessary for Immediate Breast Reconstruction? Results of a Prospective Randomized Clinical Trial. J Am Coll Surg. 2016 Jun;222(6):1116-24. doi: 10.1016/j.jamcollsurg.2016.02.018. Epub 2016 Mar 4.
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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.
Duc T Bui, MD principal investigator
Stony Brook University Medical Center
Brett T Phillips, MD study director
Stony Brook University Medical Center
Duc T Bui, MD study chair
Stony Brook University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefadroxil discontinued early and Cefadroxil until drain removal in people with Bacterial Infection and Anti-infective Agents, run by Stony Brook University at 1 site in United States.
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 2 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 13 May 2014. 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 United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (time frame: 365 days after the procedure). 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 NCT01244698, 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 13 May 2014.