Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection
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).
Timeline
- Start
- 2015-10
- Primary completion
- 2019-06
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cefazolin | Small molecule | — | Subcutaneous |
| Comparator | Epinephrine | Other / unclassified | 0.001 mg/ml | Subcutaneous |
| Comparator | Lidocaine | Other / unclassified | 1 mg/ml | Subcutaneous |
| Comparator | Metronidazole | Small molecule | — | Subcutaneous |
| Comparator | sodium bicarbonate | Diagnostic / imaging agent | 0.01 meq | Subcutaneous |