Surgical Site InfectionASSERTNCT04631185
Surgical Site Infection and Antibiotic Use Study
A study testing Single pre-operative dose of intravenous antibiotics with intraoperative redosing and One week of post-operative antibiotics in people with Surgical Site Infection and Breast Reconstruction, run by The Plastic Surgery Foundation at 5 sites in United States.
Trial summary
This study is a prospective, multi-institutional, noninferiority, randomized control trial that will compare the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with tissue expanders (TE-BR). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Site Infection, Breast Reconstruction, Antibiotic Use
- What is being tested?
- Single pre-operative dose of intravenous antibiotics with intraoperative redosing and One week of post-operative antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 May 2021to 20 May 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years or older, undergoing unilateral or bilateral mastectomy (including breast cancer, any stage, or prophylactic) and immediate tissue expander reconstruction (including submuscular, submuscular and ADM, or pre-pectoral placement).
Who cannot join
- Breast cancer patients not undergoing mastectomy
- Patients undergoing direct-to-implant reconstruction
- Patients undergoing delayed reconstruction
- Patients having autologous reconstruction
- History of radiation to the breast or chest
- History of previous breast reconstruction on the side of expander placement
- 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 at the time of enrollment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21205
The University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Antibiotics and Surgical Site Infection in Expander Based Breast Reconstruction Trial (ASSERT) A Multi-institutional Randomized Controlled Trial to Determine the Optimal Antibiotic Prophylaxis for Tissue Expander-based Breast Reconstruction
This study is a prospective, multi-institutional, noninferiority, randomized control trial that will compare the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with tissue expanders (TE-BR). The patients will be randomly assigned to one of the two treatment groups. One group will receive a single dose of antibiotics just before surgery and if necessary, more doses during the surgery. The other group will receive the same treatment as the first group, along with an additional week of antibiotics after surgery. The study will assess the rates of SSI from the two groups. It will also assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group.
Read the detailed description
Among plastic surgeons, the clinical practice of prescribing postoperative prophylactic antibiotics following postmastectomy breast reconstruction with tissue expanders ranges widely from no postoperative antibiotics, to 5-7 days post-op, to antibiotics until the drains are removed. The Centers for Disease Control and Prevention (CDC) recommends a single preoperative antibiotic dose for clean and clean-contaminated procedures, even in the presence of a drain. With the CDC creating a national action plan to reduce unnecessary prophylactic antibiotics for clean non-contaminated cases by advocating use of only a single pre-operative dose of antibiotics (see: https://www.cdc.gov/drugresistance/pdf/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf ) there is mounting pressure on the plastic surgery community to adopt this regimen of SSI prophylaxis. Because there are no definitive studies that provide sufficient or conclusive evidence to affect antibiotic practice patterns among plastic surgeons on a large-scale, plastic surgeons use a wide variety of protocols for their SSI prophylaxis, especially in implant-based breast reconstruction. Plastic surgeons have generally not adopted CDC guidelines because these recommendations were not based on studies in plastic surgery patients, and the use of foreign body implants underneath devitalized soft tissue can be associated with higher infection risks. Based on the literature and from self-reporting from ASPS membership, there is a wide range of prophylactic antibiotic use to prevent SSI from as little as one preoperative dose to many weeks of therapy; one week of post-operative antibiotics is the most common form. However, the Centers for Disease Control (CDC) recommends a single preoperative dose of antibiotics for clean cases, even in the presence of a drain. Prolonged antibiotic courses can lead to antibiotic complications and development of resistance.
Definitive studies to determine an optimal therapeutic strategy to prevent SSI in implant-based plastic surgical procedures are lacking. This study will address a dilemma in common plastic surgical operation: the use of post-operative antibiotics in prosthesis-based breast reconstruction.
The central hypothesis for this multi-institutional, prospective randomized control trial (RCT) is that a single pre-operative dose of intravenous antibiotics with intraoperative redosing (SPD) is no worse (noninferiority design) at preventing SSI in tissue expander-based breast reconstruction (TE-BR) than an additional week of post-operative antibiotic prophylaxis (WPO).
This trial will evaluate the efficacy of single preoperative dose versus one-week antibiotic regimens in preventing surgical site infection after tissue expander breast reconstruction. The investigators will assess the rates of SSI from the SPD vs. the WPO groups. They will assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group. The study will also compare the readmission and premature expander removal rates due to SSI and the adverse antibiotic side effects in the two groups.
- Being tested
- Single pre-operative dose of intravenous antibiotics with intraoperative redosing, One week of post-operative antibiotics
- 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.
Single pre-operative dose of intravenous antibiotics with intraoperative redosingDrug
Intravenous cefazolin, a cephalosporin antibiotic, will be prescribed to all patients before surgery. In case of allergy to cefazolin, intravenous clindamycin will be prescribed. For allergy to both antibiotics, an appropriate antibiotic should be chosen by the surgeon and documented. All patients will receive one dose of antibiotic within 60 minutes prior to incision, and any intraoperative doses of antibiotics according to current recommendations based on the antibiotic's dosing and on operative time.
One week of post-operative antibioticsDrug
The patients will be prescribed one week of Cephalosporin Antibiotic (Keflex/Duricef/Other) of their surgeon's choice.
| Study group | Role | What they receive |
|---|---|---|
| SPD (Arm A) | Active comparator | Single pre-operative dose of intravenous antibiotics with intraoperative redosing (SPD): Intravenous cefazolin, a cephalosporin antibiotic, will be prescribed to all patients before surgery. All patients will receive one dose of antibiotic within 60 minutes prior to incision, and any intraoperative doses of antibiotics according to current recommendations based on the antibiotic's dosing and on operative time. Receives: Drug: Single pre-operative dose of intravenous antibiotics with intraoperative redosing |
| WPO (Arm B) | Experimental | The patients assigned to this arm will receive same pre-op and intraoperative antibiotics similar to SPD (Arm A). In addition, patients in this group will receive one week of post-operative antibiotics (WPO). The post-operative antibiotic will be a first generation Cephalosporin of their surgeon's choice. Receives: Drug: Single pre-operative dose of intravenous antibiotics with intraoperative redosing; Drug: One week of post-operative antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in each group who develop surgical site infection (SSI) within 30 days of index procedure.
Surgical site infection as defined by CDC criteria within 30 days after the index procedure
Measured: Up to 30 days after the index procedure
Secondary outcomes (6)
Number of participants in each group with antibiotic-related adverse events and the type of adverse events reported.
Antibiotic-related adverse events, e.g. colitis, yeast infections, anaphylaxis, etc.
Measured: Up to 30 days after the index procedure
Number of participants in each group who develop an SSI or other complications after 30 days of index procedure.
SSI beyond 30 days after the index procedure up to the time of tissue expander exchange (for an implant or flap)
Measured: Up to two years
Number of participants in each group who undergo premature tissue expander or implant removal.
Tissue expander or implant removal, per breast and per patient events will be calculated
Measured: From index procedure until expander removal
Type, duration and route of antibiotic administration (Oral or Intravenous) in participants in each group who develop SSI/deep infections.
Antibiotic sensitivities in SSI/deep infections,
Measured: Up to two Years
Comparison of any secondary infections, including resistant bacterial strains and yeast infections, in participants from the two groups who develop SSI.
Speciation of any cultures from wound or tissue samples derived from participants in each group who develop SSI will be performed
Measured: Up to two Years
ER visit and hospital readmission rates among participants in both groups.
Length of hospitalization, need for surgery, extent of surgery (e.g. wound revision, loss of implant) will be assessed. ER visit and hospitalization rates will be recorded for comparison between the two groups
Measured: Up to two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start7 May 2021
- Primary completion31 Dec 2023
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Plastic Surgery Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Rohde, MD, MPH, Principal investigator, Columbia UniversityBrian Gastman, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631185
- Sponsor's protocol ID
- PSF 19-03-SSI Study
- Acronym
- ASSERT
- Status last verified
- May 2024
- First submitted
- 10 Nov 2020
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study sites will keep patient details under a study ID number, and not under the patient's name. Aggregate data shared between investigators will be coded and de-identified (except dates).
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics and Surgical Site Infection in Expander Based Breast Reconstruction Trial (ASSERT) A Multi-institutional Randomized Controlled Trial to Determine the Optimal Antibiotic Prophylaxis for Tissue Expander-based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04631185
- Acronym / sponsor ID
- ASSERT / PSF 19-03-SSI Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- The Plastic Surgery FoundationUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 17 Nov 2020 (actual)
- 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 study is a prospective, multi-institutional, noninferiority, randomized control trial that will compare the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with tissue expanders (TE-BR). The patients will be randomly assigned to one of the two treatment groups. One group will receive a single dose of antibiotics just before surgery and if necessary, more doses during the surgery. The other group will receive the same treatment as the first group, along with an additional week of antibiotics after surgery. The study will assess the rates of SSI from the two groups. It will also assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group.
Detailed description
Among plastic surgeons, the clinical practice of prescribing postoperative prophylactic antibiotics following postmastectomy breast reconstruction with tissue expanders ranges widely from no postoperative antibiotics, to 5-7 days post-op, to antibiotics until the drains are removed. The Centers for Disease Control and Prevention (CDC) recommends a single preoperative antibiotic dose for clean and clean-contaminated procedures, even in the presence of a drain. With the CDC creating a national action plan to reduce unnecessary prophylactic antibiotics for clean non-contaminated cases by advocating use of only a single pre-operative dose of antibiotics (see: https://www.cdc.gov/drugresistance/pdf/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf ) there is mounting pressure on the plastic surgery community to adopt this regimen of SSI prophylaxis. Because there are no definitive studies that provide sufficient or conclusive evidence to affect antibiotic practice patterns among plastic surgeons on a large-scale, plastic surgeons use a wide variety of protocols for their SSI prophylaxis, especially in implant-based breast reconstruction. Plastic surgeons have generally not adopted CDC guidelines because these recommendations were not based on studies in plastic surgery patients, and the use of foreign body implants underneath devitalized soft tissue can be associated with higher infection risks. Based on the literature and from self-reporting from ASPS membership, there is a wide range of prophylactic antibiotic use to prevent SSI from as little as one preoperative dose to many weeks of therapy; one week of post-operative antibiotics is the most common form. However, the Centers for Disease Control (CDC) recommends a single preoperative dose of antibiotics for clean cases, even in the presence of a drain. Prolonged antibiotic courses can lead to antibiotic complications and development of resistance.
Definitive studies to determine an optimal therapeutic strategy to prevent SSI in implant-based plastic surgical procedures are lacking. This study will address a dilemma in common plastic surgical operation: the use of post-operative antibiotics in prosthesis-based breast reconstruction.
The central hypothesis for this multi-institutional, prospective randomized control trial (RCT) is that a single pre-operative dose of intravenous antibiotics with intraoperative redosing (SPD) is no worse (noninferiority design) at preventing SSI in tissue expander-based breast reconstruction (TE-BR) than an additional week of post-operative antibiotic prophylaxis (WPO).
This trial will evaluate the efficacy of single preoperative dose versus one-week antibiotic regimens in preventing surgical site infection after tissue expander breast reconstruction. The investigators will assess the rates of SSI from the SPD vs. the WPO groups. They will assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group. The study will also compare the readmission and premature expander removal rates due to SSI and the adverse antibiotic side effects in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPD (Arm A) | Active comparator | Drug: Single pre-operative dose of intravenous antibiotics with intraoperative redosingSingle pre-operative dose of intravenous antibiotics with intraoperative redosing (SPD): Intravenous cefazolin, a cephalosporin antibiotic, will be prescribed to all patients before surgery. All patients will receive one dose of antibiotic within 60 minutes prior to incision, and any intraoperative doses of antibiotics according to current recommendations based on the antibiotic's dosing and on operative time. |
| WPO (Arm B) | Experimental | Drug: Single pre-operative dose of intravenous antibiotics with intraoperative redosing, Drug: One week of post-operative antibioticsThe patients assigned to this arm will receive same pre-op and intraoperative antibiotics similar to SPD (Arm A). In addition, patients in this group will receive one week of post-operative antibiotics (WPO). The post-operative antibiotic will be a first generation Cephalosporin of their surgeon's choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women 18 years or older, undergoing unilateral or bilateral mastectomy (including breast cancer, any stage, or prophylactic) and immediate tissue expander reconstruction (including submuscular, submuscular and ADM, or pre-pectoral placement).
Key exclusion criteria (7 listed)
- Breast cancer patients not undergoing mastectomy
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 |
|---|---|---|
| Single pre-operative dose of intravenous antibiotics with intraoperative redosingIntravenous cefazolin, a cephalosporin antibiotic, will be prescribed to all patients before surgery. In case of allergy to cefazolin, intravenous clindamycin will be prescribed. For allergy to both antibiotics, an appropriate antibiotic should be chosen by the surgeon and documented. All patients will receive one dose of antibiotic within 60 minutes prior to incision, and any intraoperative doses of antibiotics according to current recommendations based on the antibiotic's dosing and on operative time. | Drug | SPD (Arm A), WPO (Arm B) |
| One week of post-operative antibioticsThe patients will be prescribed one week of Cephalosporin Antibiotic (Keflex/Duricef/Other) of their surgeon's choice. | Drug | WPO (Arm B) |
Primary outcome
Number of participants in each group who develop surgical site infection (SSI) within 30 days of index procedure.
Time frame: Up to 30 days after the index procedure
Surgical site infection as defined by CDC criteria within 30 days after the index procedure
6 secondary outcomes
Number of participants in each group with antibiotic-related adverse events and the type of adverse events reported.
Time frame: Up to 30 days after the index procedure
Number of participants in each group who develop an SSI or other complications after 30 days of index procedure.
Time frame: Up to two years
Number of participants in each group who undergo premature tissue expander or implant removal.
Time frame: From index procedure until expander removal
Type, duration and route of antibiotic administration (Oral or Intravenous) in participants in each group who develop SSI/deep infections.
Time frame: Up to two Years
Comparison of any secondary infections, including resistant bacterial strains and yeast infections, in participants from the two groups who develop SSI.
Time frame: Up to two Years
ER visit and hospital readmission rates among participants in both groups.
Time frame: Up to two Years
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 29 May 2024.
- Individual participant dataSharing planned: No. The study sites will keep patient details under a study ID number, and not under the patient's name. Aggregate data shared between investigators will be coded and de-identified (except dates).
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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.
Christine Rohde, MD, MPH principal investigator
Columbia University
Brian Gastman, MD principal investigator
The Cleveland Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single pre-operative dose of intravenous antibiotics with intraoperative redosing and One week of post-operative antibiotics in people with Surgical Site Infection and Breast Reconstruction, run by The Plastic Surgery Foundation at 5 sites 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 1 inclusion and 7 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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?
Number of participants in each group who develop surgical site infection (SSI) within 30 days of index procedure. (time frame: Up to 30 days after the index procedure). 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 29 May 2024.