Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection
1 other identifier
interventional
400
0 countries
N/A
Brief 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). 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2015
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2014
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 21, 2015
July 1, 2015
3.7 years
December 26, 2014
July 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of surgical site infections
30 days
Secondary Outcomes (4)
Number of post-operative venous thromboembolism
30 days
Amount of postoperative narcotic required
7 days
Hospital length of stay
30 days
Number of participants with adverse events
24 hours
Study Arms (2)
TAD+IVAD
ACTIVE COMPARATORIVAD
ACTIVE COMPARATORInterventions
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 infiltration using HK tumescent infiltration cannulas and HK tumescent infiltration pump
Eligibility Criteria
You may qualify if:
- \. 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.
- \. 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.
- \. 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.
- \. 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.
- \. 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.
- \. Patients must be appropriately screened for the proposed surgery.
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2014
First Posted
July 21, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2019
Study Completion
December 1, 2019
Last Updated
July 21, 2015
Record last verified: 2015-07