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Surgery Research

Study Title:  Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI).  (Identifier NCT02060630)

Study Purpose:  This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.

Principal Investigator: Munier Nazzal, MD

Study Coordinator:   Christina Sattler, RN, BSN, CCRC, 419.383.6784


Study Title:  A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiac Surgery with Cardiopulmonary Bypass. (Identifier NCT02037555)

Study Purpose:  This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III [Human]) supplementation prior to high-risk, non-emergency, cardiac surgery with cardiopulmonary bypass (CPB). A total of 404 adult subjects undergoing CPB who meet the study eligibility criteria will be randomized to receive either AT-III (Human) or placebo.

Principal Investigator: Thomas Schwann, MD

Study Coordinator:   Christina Sattler, RN, BSN, CCRC, 419.383.6784


Study Title:  Vascular Outcomes studY of ASA alonG with Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease (PAD) (VOYAGER) (Identifier NCT02504216)

Study Purpose:  The purpose of study is to test whether rivaroxaban added to standard of care treatment, when compared to placebo, has the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.

Principal Investigator: Munier Nazzal, MD

Study Coordinator:   Christina Sattler, RN, BSN, CCRC, 419.383.6784


Study Title:  Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) (Identifier NCT02089217)

Study Purpose:  Carotid revascularization for primary prevention of stroke (CREST-2) is two independent, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis.  One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients with a 1:1 ratio to carotid stenting with embolic protection versus no stenting.  Medical management will be uniform for all randomized treatment groups and will be centrally directed.

Principal Investigator: Munier Nazzal, MD

Study Coordinator:   Christina Sattler, RN, BSN, CCRC, 419.383.6784


Study Title:  Patient Perceptions of Care:  The Effects of Social Determinants of Health

Study Purpose:  The primary objective is to connect patients with community resources to improve social determinants of health.  Secondary objectives are improving patient satisfaction within the trauma and general surgery service, enhancement of physician-patient communication, betterment of surgery department HCAHPS scores, and increasing understanding of correlations between patient satisfaction and social determinants of health.

Principal Investigator: David Heidt, MD

Study Coordinator:   Christina Sattler, RN, BSN, CCRC, 419.383.6784


Study Title:  A Comparison of Incisional Negative Pressure Wound Therapy vs Standard Care for Vascular, Plastics and General Surgery Procedures

Study Purpose:  The purpose of the study is to compare the SSI incidence and average hospital length of stay between Prevena use (negative pressure wound therapy) and dry gauze dressing use in patients hospitalized following general surgery or vascular surgery. Null hypothesis is there is no difference exists between Prevena and dry gauze dressing use in terms of incidence of SSI and wound healing. Alternative hypothesis is there is a difference between Prevena and dry gauze dressing use in terms of SSI and wound healing.

Principal Investigator: Munier Nazzal, MD

Study Coordinator:   Christina Sattler, RN, BSN, CCRC, 419.383.6784


 

 

Last Updated: 4/24/18