Surgical Site InfectionsPhase 2/3NCT02503904
Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection
A Phase 2/3 study testing Concomitant Tumescent Antibiotic Delivery & IV Delivery, Subcutaneous Tumescent Infiltration and cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline) in people with Surgical Site Infections and Venous Thromboembolism, run by Klein, Jeffrey A., M.D..
Trial summary
The principal aim of the present research is to compare two methods of antibiotic delivery: concomitant tumescent antibiotic delivery (TAD) and intravenous antibiotic delivery (IVAD) versus IVAD alone, (TAD+IVAD vs IVAD), with respect to the prevention of surgical site infections (SSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infections, Venous Thromboembolism
- What is being tested?
- Concomitant Tumescent Antibiotic Delivery & IV Delivery, Subcutaneous Tumescent Infiltration and cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2019
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects greater than 18 years of age scheduled for surgical procedure considered to have a high risk for a surgical site infection (SSI) such as 1) secondary repair of a ventral hernia, 2) open bariatric surgery, 3) open abdominal colorectal surgery, 4) trauma surgery, 5) burn surgery or 6) sternotomy.
- 2. Patients must have one of the following risk factors for surgical site infection: emergency surgery, obesity, diabetes mellitus, cancer surgery, be immune-compromised or otherwise be at an increased risk for SSI.
- 3. Only adults will participate as research subjects 4. This study will involve both males and females 5. Patients in ASA (American Society of Anesthesiology) class I or II or III or IV will be included. Treatment assignment will be stratified with respect to ASA classification.
- 6. Abdominal wound classifications: Clean-Contaminated, Contaminated, or Dirty are eligible to participate. Treatment assignment will be stratified with respect wound classification. Similarly, trauma and burn patients will be classified.
- 7. Patient must be able to understand the same written and spoken language as either the surgeon or nurse who provides informed-consent information to the patient.
- 8. Patients must be appropriately screened for the proposed surgery.
Who cannot join
- Procedures involving only simple ostomy closures 2. Known allergy to cefazolin or metronidazole or an antibiotic preferred and routinely used by the surgeon 3. Persons less than 18 years old 4. Emergency operation as designated by the surgeon will be included only with the appropriate approval by the institutional IRB at an individual research site 5. Pregnant or breast-feeding women 6. A known bleeding/hemorrhagic/thrombotic disorder is exclusionary unless there is a written clearance chart-note or clearance letter from a primary care physician or hematologist 7. Significant psychiatric problems which might impair ability to give truly informed consent or which may impair follow-up communication with the surgeon and staff 8. Clinically significant cardiac arrhythmias are exclusionary unless there is a written clearance chart-note or clearance letter from a cardiologist 9. Heart/liver/kidney disease, neuropsychiatric disease classifying patient as ≥ ASA V 10. Major concomitant infections such as pneumonia or sepsis 11. In non-emergency surgery, pre-existing active bacterial skin infection at the time of the surgical incision; however, pre-existing bacterial infections are not exclusionary in burn or trauma patients.
- 12. Foreign material in the incision that cannot be removed 13. Recent systemic antimicrobial therapy 14. Clinically significant renal impairment or a creatinine clearance < 30 mL/min.
- Vulnerable Subjects are excluded
- Pregnant women
- Nursing home residents, or other institutionalized persons are not fully alert, not cognizant or and not able to give informed consent are not eligible to participate as a research subject
- Children < 18 years of age
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection: A Multicenter Open Label Randomized Clinical Trial
The principal aim of the present research is to compare two methods of antibiotic delivery: concomitant tumescent antibiotic delivery (TAD) and intravenous antibiotic delivery (IVAD) versus IVAD alone, (TAD+IVAD vs IVAD), with respect to the prevention of surgical site infections (SSI). The investigators hypothesize that TAD+IVAD will significantly reduce the incidence of SSI compared to IVAD.
TAD is the subcutaneous infiltration of a dilute solution of antibiotic(s) in a solution of tumescent local anesthesia (TLA). TLA consists of a dilute solution of lidocaine (1gm/L), epinephrine (1mg/L) and sodium bicarbonate (10mEq/L) in 0.9% physiologic saline.
A secondary aim of this study is to compare TAD+IVAD vs IVAD with respect to the prevention of post-operative venous thromboembolism (VTE).
Read the detailed description
Tumescent antibiotic delivery (TAD) is defined as the subcutaneous infiltration of a dilute solution of antibiotic(s) in a solution of tumescent local anesthesia (TLA). TLA consists of a dilute solution of lidocaine (1gm/L), epinephrine (1mg/L) and sodium bicarbonate (10mEq/L) in 0.9% physiologic saline.
The investigators hypothesize that TAD with intravenous antibiotic delivery (IVAD) will significantly reduce the incidence of SSI.
The Principal aim of the present research is to compare two methods of antibiotic delivery: concomitant TAD and IVAD versus IVAD alone (TAD+IVAD vs IVAD) with respect to the prevention of surgical site infections (SSI). The secondary aim of this study is to compare TAD+IVAD vs IVAD with respect to the prevention of post-operative venous thromboembolism (VTE). This research is an open label randomized clinical trial (RCT) comparing two modes of antibiotic delivery. It is not a trial comparing antibiotics.
The target populations for the present clinical trial are patients who have a high risk of SSI. These include patients exposed to high-risk surgical procedures (open abdominal surgeries, trauma surgeries, burn surgeries, sternotomy) or are obese, have diabetes, are immune-compromised or are otherwise at increased risk of SSI.
- Conditions
- Surgical Site Infections, Venous Thromboembolism
- Being tested
- Concomitant Tumescent Antibiotic Delivery & IV Delivery, Subcutaneous Tumescent Infiltration, cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline)
- Keywords
- Pharmacology, Lidocaine, Epinephrine, Cefazolin, Metronidazole, Infection, prevention, prophylaxis, SSI, Surgery, Complications
- Medical subject headings
- Surgical Wound Infection, Venous Thromboembolism, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concomitant Tumescent Antibiotic Delivery & IV DeliveryProcedure or surgery
Also called TAD+IVAD
Concomitant subcutaneous infiltration of a dilute antibiotics (cefazolin and metronidazole) in a dilute solution of tumescent lidocaine and epinephrine at the site of a proposed surgical incision.
Subcutaneous Tumescent InfiltrationDevice
Subcutaneous tumescent infiltration using HK tumescent infiltration cannulas and HK tumescent infiltration pump
cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline)Drug
| Study group | Role | What they receive |
|---|---|---|
| TAD+IVAD | Active comparator | Not described Receives: Procedure: Concomitant Tumescent Antibiotic Delivery & IV Delivery; Device: Subcutaneous Tumescent Infiltration; Drug: cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline) |
| IVAD | Active comparator | Not described Receives: Procedure: Concomitant Tumescent Antibiotic Delivery & IV Delivery; Drug: cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of surgical site infections
Measured: 30 days
Secondary outcomes (4)
Number of post-operative venous thromboembolism
Measured: 30 days
Amount of postoperative narcotic required
Measured: 7 days
Hospital length of stay
Measured: 30 days
Number of participants with adverse events
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionsStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klein, Jeffrey A., M.D.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503904
- Sponsor's protocol ID
- TAD4SSI
- Status last verified
- Jul 2015
- First submitted
- 26 Dec 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection: A Multicenter Open Label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02503904
- Acronym / sponsor ID
- TAD4SSI
- Conditions
- Surgical Site Infections, Venous Thromboembolism
- Keywords
- Pharmacology, Lidocaine, Epinephrine, Cefazolin, Metronidazole, Infection, prevention, prophylaxis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Klein, Jeffrey A., M.D.
- Study start
- Oct 2015
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Jul 2015 (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.
The principal aim of the present research is to compare two methods of antibiotic delivery: concomitant tumescent antibiotic delivery (TAD) and intravenous antibiotic delivery (IVAD) versus IVAD alone, (TAD+IVAD vs IVAD), with respect to the prevention of surgical site infections (SSI). The investigators hypothesize that TAD+IVAD will significantly reduce the incidence of SSI compared to IVAD.
TAD is the subcutaneous infiltration of a dilute solution of antibiotic(s) in a solution of tumescent local anesthesia (TLA). TLA consists of a dilute solution of lidocaine (1gm/L), epinephrine (1mg/L) and sodium bicarbonate (10mEq/L) in 0.9% physiologic saline.
A secondary aim of this study is to compare TAD+IVAD vs IVAD with respect to the prevention of post-operative venous thromboembolism (VTE).
Detailed description
Tumescent antibiotic delivery (TAD) is defined as the subcutaneous infiltration of a dilute solution of antibiotic(s) in a solution of tumescent local anesthesia (TLA). TLA consists of a dilute solution of lidocaine (1gm/L), epinephrine (1mg/L) and sodium bicarbonate (10mEq/L) in 0.9% physiologic saline.
The investigators hypothesize that TAD with intravenous antibiotic delivery (IVAD) will significantly reduce the incidence of SSI.
The Principal aim of the present research is to compare two methods of antibiotic delivery: concomitant TAD and IVAD versus IVAD alone (TAD+IVAD vs IVAD) with respect to the prevention of surgical site infections (SSI). The secondary aim of this study is to compare TAD+IVAD vs IVAD with respect to the prevention of post-operative venous thromboembolism (VTE). This research is an open label randomized clinical trial (RCT) comparing two modes of antibiotic delivery. It is not a trial comparing antibiotics.
The target populations for the present clinical trial are patients who have a high risk of SSI. These include patients exposed to high-risk surgical procedures (open abdominal surgeries, trauma surgeries, burn surgeries, sternotomy) or are obese, have diabetes, are immune-compromised or are otherwise at increased risk of SSI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAD+IVAD | Active comparator | Procedure: Concomitant Tumescent Antibiotic Delivery & IV Delivery, Device: Subcutaneous Tumescent Infiltration, Drug: cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline) |
| IVAD | Active comparator | Procedure: Concomitant Tumescent Antibiotic Delivery & IV Delivery, Drug: cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Subjects greater than 18 years of age scheduled for surgical procedure considered to have a high risk for a surgical site infection (SSI) such as 1) secondary repair of a ventral hernia, 2) open bariatric surgery, 3) open abdominal colorectal surgery, 4) trauma surgery, 5) burn surgery or 6) sternotomy.
- 2. Patients must have one of the following risk factors for surgical site infection: emergency surgery, obesity, diabetes mellitus, cancer surgery, be immune-compromised or otherwise be at an increased risk for SSI.
- 3. Only adults will participate as research subjects 4. This study will involve both males and females 5. Patients in ASA (American Society of Anesthesiology) class I or II or III or IV will be included. Treatment assignment will be stratified with respect to ASA classification.
- 6. Abdominal wound classifications: Clean-Contaminated, Contaminated, or Dirty are eligible to participate. Treatment assignment will be stratified with respect wound classification. Similarly, trauma and burn patients will be classified.
- 7. Patient must be able to understand the same written and spoken language as either the surgeon or nurse who provides informed-consent information to the patient.
Key exclusion criteria (6 listed)
- Procedures involving only simple ostomy closures 2. Known allergy to cefazolin or metronidazole or an antibiotic preferred and routinely used by the surgeon 3. Persons less than 18 years old 4. Emergency operation as designated by the surgeon will be included only with the appropriate approval by the institutional IRB at an individual research site 5. Pregnant or breast-feeding women 6. A known bleeding/hemorrhagic/thrombotic disorder is exclusionary unless there is a written clearance chart-note or clearance letter from a primary care physician or hematologist 7. Significant psychiatric problems which might impair ability to give truly informed consent or which may impair follow-up communication with the surgeon and staff 8. Clinically significant cardiac arrhythmias are exclusionary unless there is a written clearance chart-note or clearance letter from a cardiologist 9. Heart/liver/kidney disease, neuropsychiatric disease classifying patient as ≥ ASA V 10. Major concomitant infections such as pneumonia or sepsis 11. In non-emergency surgery, pre-existing active bacterial skin infection at the time of the surgical incision; however, pre-existing bacterial infections are not exclusionary in burn or trauma patients.
- 12. Foreign material in the incision that cannot be removed 13. Recent systemic antimicrobial therapy 14. Clinically significant renal impairment or a creatinine clearance < 30 mL/min.
- Vulnerable Subjects are excluded
- Pregnant women
- Nursing home residents, or other institutionalized persons are not fully alert, not cognizant or and not able to give informed consent are not eligible to participate as a research subject
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 |
|---|---|---|
| Concomitant Tumescent Antibiotic Delivery & IV DeliveryAlso: TAD+IVADConcomitant subcutaneous infiltration of a dilute antibiotics (cefazolin and metronidazole) in a dilute solution of tumescent lidocaine and epinephrine at the site of a proposed surgical incision. | Procedure or surgery | IVAD, TAD+IVAD |
| Subcutaneous Tumescent InfiltrationSubcutaneous tumescent infiltration using HK tumescent infiltration cannulas and HK tumescent infiltration pump | Device | TAD+IVAD |
| cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline) | Drug | IVAD, TAD+IVAD |
Primary outcome
Number of surgical site infections
Time frame: 30 days
4 secondary outcomes
Number of post-operative venous thromboembolism
Time frame: 30 days
Amount of postoperative narcotic required
Time frame: 7 days
Hospital length of stay
Time frame: 30 days
Number of participants with adverse events
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Concomitant Tumescent Antibiotic Delivery & IV Delivery, Subcutaneous Tumescent Infiltration and cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline) in people with Surgical Site Infections and Venous Thromboembolism, run by Klein, Jeffrey A., M.D..
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 6 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: status not confirmed, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey A Klein, MD (949-283-1070, jeff@kleinmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of surgical site infections (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 21 Jul 2015.