Venous Thromboembolism Clinical Trial
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05347550 -
Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
|
N/A | |
| Enrolling by invitation |
NCT05794165 -
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
|
Phase 2 | |
| Completed |
NCT02379806 -
The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study
|
Phase 3 | |
| Recruiting |
NCT03691753 -
Safety and Efficacy Study of Fitaya Vena Cava Filter
|
N/A | |
| Completed |
NCT02197416 -
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
|
Phase 3 | |
| Recruiting |
NCT05378035 -
DOAC in Chinese Patients With Atrial Fibrillation
|
||
| Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
| Completed |
NCT01895777 -
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
|
Phase 3 | |
| Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
| Completed |
NCT04736420 -
Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
|
||
| Completed |
NCT04735523 -
Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
|
||
| Completed |
NCT04736719 -
Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
|
||
| Completed |
NCT02829957 -
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
|
Phase 2/Phase 3 | |
| Completed |
NCT02912234 -
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants
|
Phase 1 | |
| Completed |
NCT02746185 -
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
|
Phase 3 | |
| Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
| Completed |
NCT02223260 -
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
|
Phase 2 | |
| Completed |
NCT02661568 -
Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)
|
N/A | |
| Completed |
NCT01431456 -
Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery
|
Phase 3 | |
| Completed |
NCT01976988 -
Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery
|
Phase 3 |