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Surgery Research

Study Title:  Macitentan in pulmonary hypertenSiOn Post left ventRiculAr assist device implaNtatiOn (SOPRANO).  (Identifier NCT02554903)

Study Purpose:  To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation.

Principal Investigator: Mark Bonnell, MD

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


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 Multi-center, Randomized, Open-Label, Controlled Clinical Trial Evaluating Suction Blister Grafting Utilizing a Novel Harvesting Device (CelluTome©) and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers.  (Identifier NCT02148302)

Study Purpose:  Epidermal grafts are believed to promote healing by two mechanisms: graft take and the promotion of wound healing through the delivery of growth factors and the essential elements of tissue repair and wound healing. This study is intended to establish the superior effectiveness of epidermal grafting and multi-layer compression over that of multi-layer compression alone, in the treatment of venous leg ulcers.  Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs). Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain.  Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Epidermal grafting has been a reconstructive option for decades; however, to date there has not been a reliable and reproducible system to harvest epidermis. The CelluTome® Harvesting System permits the harvesting of epidermal blister grafts at the patient's bedside without the need for anesthesia. The grafts can be easily transferred to the wound bed. In case studies, epidermal grafting appeared to be effective in reducing wound size and accelerating closure of venous leg ulcers.

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


 

 

Last Updated: 9/11/17