Clinical Trials

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ANESTHESIA STUDIES

 

  1. Completed 2011 Regional vs. General Anesthesia for Laparoendoscopic Single Site Cholecystectomies (LESS)
  2. Investigator Initiated

    Investigators: Sharona Ross MD, Enrico Camporesi MD, Devanand Mangar MD, John Basile MD, Alexander Rosemurgy MD, Michael Albrink MD.

    The purpose of this study is to determine if a combination of spinal and epidural anesthesia gives better pain control and faster recovery from the surgery than the standard general anesthesia.

     

  3. Completed 2011 Postoperative Knee Strength Following Total Knee Replacement: A Double-Blinded Randomized Comparison Study
  4. Investigator Initiated

    Investigators: Devanand Mangar MD, Thomas Bernasek MD, Kenneth Gustke MD, John P McDonough CRNA, EdD, ARNP, Narrene Taffe CRNA, Robert Wainwright CRNA

    The purpose of this study is to find out if administering one of two medications, fentanyl or ropivacaine, through a tube that is placed beside the femoral nerve in the leg (femoral nerve catheter) is as good as or better than administering fentanyl directly into a vein (IV) in the arm to help recover leg strength after total knee replacement surgery. 

     

  5. Completed 2011 Proper Insertion Depth of the Kimberly-Clark Microcuff Endotracheal Tube: Traditional vs. Topographic Method
  6. Investigator Initiated

    Investigators: Devanand Mangar MD, Bill H. Brashears CRNA, Robert Dodson CRNA

    The purpose of this study is to confirm the proper depth of insertion for the endotracheal tube currently being used at TGH

     

  7. Completed 2012 Intraoperative Warming: Comparison of performance of the Dynatherm Medical vitalHEAT™ Temperature Management System (vH2) and the Arizant Bair Hugger Temperature Management System
  8. Sponsored by Dynatherm

    Investigators: Enrico Camporesi MD, Devanand Mangar MD

    The purpose of this study is to collect data comparing two warming devices, Dynatherm sleeve to Arizant Bair Hugger, while a patient is under anesthesia.

     

  9. Completed 2012 A Prospective, Double-blinded, Randomized Study to Determine Analgesic Efficacy of Ketorolac vs Ofirmev for Parathyroidectomy Post-Operative Pain
  10. Investigator Initiated

    Investigators: Amrat Anand MD, Devanand Mangar MD, James Norman MD, Roger Southall BSN, SRNA, Bruce Wilburn BSN, SRNA

    The purpose of this study is to find out which one of two medications, Ketorolac or Ofirmev (IV acetaminophen) will help relieve pain the most after surgery and which has the most side effects.

     

  11. 10/1/12-Current New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway: A Prospective, Randomized Study
  12. Investigator Initiated

    Investigators: Devanand Mangar MD, Tapan Padhya MD

    The “tongue pulling maneuver,” which consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met, is proposed to be used in conjunction with fiberoptic intubation to facilitate intubations.

     

  13. Pending Approval Total Intravenous Anesthesia and versus Inhalation Anesthesia for Total Shoulder Arthroplasty: A Randomized Controlled Pilot Study
  14. Investigator Initiated

    Investigators: Devanand Mangar MD, Mark Frankle MD, Jeff Hamlin PA

    The purpose of this study is to compare TIVA to gas anesthesia for assessment of intraoperative narcotic requirement, postoperative adverse effects, pain and recovery. Nerve monitoring and EMG data will also be collected to assess incidence and pattern of nerve injury during shoulder arthroplasty for TIVA group.

     

  15. Pending Approval Systemic Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients: A Randomized Controlled Pilot Study
  16. Investigator Initiated

    Investigators: Enrico M. Camporesi MD, Michel Murr MD, John Schweiger MD

    The purpose of this study is to determine if lidocaine administration versus placebo (saline administration) initiated at the time of anesthesia induction and continued until extubation will reduce postoperative narcotic requirements.

     

  17. 6/7/12- Current A Prospective, Comparative Study to Evaluate the Accuracy of a Non-Invasive Central Venous Pressure Method to the Standard CVP Method
  18. Sponsored by Neumedx

    Investigators: John Hans Schweiger MD, Enrico M Camporesi MD, Devanand Mangar MD

    The purpose of this study is to determine if the NeuMedx non-invasive CVP monitor is sufficiently accurate as to serve as an alternative to the standard invasive CVP method at measuring CVP in patients that require central catheter placement and monitoring.

 

BURN STUDIES

 

  1. 8/28/08- Current A Prospective Correlational Pilot Study of Toxic Metabolites Present In Patients with and without Inhalation Injuries
  2. Investigator-Initiated

    Investigators: David Smith MD, Devanand Mangar MD, C. Wayne Cruse MD, John Schweiger MD, Albert Kabemba MD, Kimberly Brown ARNP

    The purpose of this study is to identify toxic compounds that may worsen smoke inhalation injury. Toxic compounds are materials that are released from household products during combustion. Information provided by this study may help develop more sensitive screening tools to help determine the severity and/or outcome of an individuals’ smoke inhalation injury.

     

  3. Completed Phase I/II Prospective Randomized, Double-Blind Safety and Dose-Determining Efficacy Clinical Trial Comparing ACCS (Amnion-Derived Cellular Cytokine Solution) in Three Different Regimens with Standardized Care Using 0.9% NaCl (Saline) Solution in the Topical Treatment of Partial Thickness Burns
  4. Sponsored by Stemnion

    Investigators: David Smith MD, C. Wayne Cruse MD

    The purpose of this study is to test whether an “investigational” drug, called ACCS, can improve healing of partial-thickness burns better than standardized care using normal saline solution. ACCS is “Amnion-derived Cellular Cytokine Solution”. ACCS is made by cells from placentas taken from a normal pregnancy and scheduled Caesarean delivery.

     

  5. Completed A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of REGN475 in Patients with Pain Resulting from Thermal Injury
  6. Sponsored by Regeneron Pharmaceuticals

    Investigators: David Smith MD, C. Wayne Cruse MD

    The purpose of this study is to determine how well new, investigational pain drug REGN475 works by assessing: how well REGN475 works to relieve pain when added to normal care in patients with pain resulting from burns; the safety of REGN475 in patients with burns; the impact of REGN 475 on the anxiety associated with pain resulting from wound care; how well patients are reacting to REGN 475; the impact REGN 475 has on patients when taken with other pain medications; the drug levels of REGN475 in blood; and how patients’ burns heal when REGN475 is included in treatment. This study is a single administration study and there are two doses of REGN475 being tested (0.1 and 0.3 mg/kg) along with placebo.

     

  7. Completed An open, prospective randomized pilot investigation evaluating pain with the use of a soft silicone wound contact layer, Mepitel One, vs. Bridal Veil and staples used on split thickness skin grafts as a primary dressing.
  8. Sponsored by Molnycke

    Investigators: David Smith MD, C. Wayne Cruse MD, Scott Blow PA, Kim S Brown ARNP

    The purpose of this study is to compare two types of wound dressings used on top of skin grafts. The two dressings being compared are Mepitel®One and Bridal Veil and staples. Bridal Veil is a dressing used to put over the graft and held on by staples, while Mepitel®One is a clear and easy to bend dressing that has a sticky side to allow it to stay on without using staples. Both dressings are FDA approved for use in burns. The main purpose of the study is to compare pain at the time of dressing change for each of these dressings. The study will also look at how well the dressing sticks to wounds, how well skin responds to the dressing, overall costs by Day 7, ease of use, and safety using each of these dressings.

     

  9. 7/11/11- Current The American Burn Association’s Randomized controlled Evaluation of hemofiltration in adult burn patients with Septic shoCk and acUte rEnal failure (ABA RESCUE)
  10. Sponsored by US Army Department of Defense and the American Burn Association MultiCenter Trials Group

    Investigators: David Smith MD, Christopher McFarren MD, C. Wayne Cruse MD, Kim S Brown ARNP, John Schweiger MD, Albert Kabemba MD, Attila Bescey MD, Elias Doumit MD, Jacques Durr MD, Ramon Lopez MD, Stephen Rifkin MD, Deniz Dayicioglu MD, Paul Smith MD, Sabrina Wilkins RN

    The purpose of this study is to see if using a blood cleansing procedure with a kidney therapy machine (like a dialysis machine) at a much higher than usual dose (double the dose), along with a standardized way of treating “septic shock”, will be helpful in decreasing the amount and time that you are on these strong medicines that are necessary to keep the blood pressure normal. This blood cleansing procedure is promising but has not been proven to work. 

     

  11. 6/30/11- Current A Comparative Study of the ReCell® Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
  12. Sponsored by the DOD and Avita Medical

    Investigators: David Smith MD, C. Wayne Cruse MD, Kim S Brown ARNP

    The purpose of the study is to compare a skin graft, which is prepared by the ReCell® Autologous Cell Harvesting Device, to a skin graft prepared using a skin meshing device.

    The ReCell® Autologous Cell Harvesting Device is an investigational (trial) product that is being evaluated for the treatment of second degree burns. ReCell® is a single use stand-alone; battery operated cell harvesting device containing special enzyme (protein) and delivery solutions, and sterile surgical instruments. With the ReCell® device, a small, thin piece of skin, about the size of a postage stamp (approximately 1 inch x 1 inch) can be processed to produce a number of cells. These cells are then sprayed onto a prepared wound surface. These cells are a mixture of mostly epidermal cells (the outer layer of the skin), but also includes Langerhans cells (skin cells containing proteins), melanocytes (cells that make your skin coloring), and fibroblasts (cells that form fibrous, binding and supporting body tissue). The preservation (maintenance) of melanocytes is important for restoring natural pigmentation (skin coloring) to the area being treated.

     

  13. 10/24/11-Current A Prospective, Randomized Pilot Study to Compare the Efficacy and Tolerance of Silvadene® and SilverGel on Partial-Thickness Burns
  14. Investigator Initiated

    Investigators: David Smith MD, C. Wayne Cruse MD, Kimberly Brown ARNP

    The purpose of this study is to determine if SilverGel, an FDA (Food and Drug Administration) approved topical medication for burns, can improve the pain experienced with burn dressings compared to the standard topical medication used in our hospital. The standard topical medication is called Silvadene®. Both of these topical medications contain silver and are used for burns because they are a good defense against infections and they keep the burn wound moist.

     

  15. Completed A Prospective, Internally-Controlled Study to Compare the Absorbent Capability of DrawTex Hydroconductive Dressing Versus the Standard Gauze Burn Dressing on Partial Thickness Burns
  16. Investigator Initiated

    Investigators: David Smith MD, C. Wayne Cruse MD, Kimberly Brown ARNP

    The purpose of this study is to test whether an investigational burn dressing, Drawtex, can improve healing of a superficial partial-thickness burn compared to the hospital’s standard of care dressing, gauze. Drawtex is a non-adhesive dressing that when applied to wounds, absorbs fluid and debris from the wound.

     

  17. 08/27/12-Current A Prospective, Randomized, Controlled Pilot Study of the MIST Therapy System For the Treatment of Split Thickness Donor Sites
  18. Sponsored by Celleration

    Investigators: David Smith MD, C. Wayne Cruse MD, Kim S Brown ARNP

    The purpose of the study is to determine if MIST Therapy in addition to the standard of care will help heal donor sites faster. The study will also look at wound pain, itching, and the incidence of adverse events. MIST Therapy is an ultrasound wound cleaning system that received marketing clearance from the U.S. Food and Drug Administration (FDA) in June 2004 and a second FDA clearance in May 2005. MIST Therapy utilizes ultrasound technology, which is a medical treatment that uses sound waves to treat tissues. Ultrasound can improve blood flow and increase oxygen delivery to injured or damaged tissues.

 

CARDIAC STUDIES

 

  1. May 2010–Current Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)
  2. Sponsored by the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH)

    Investigators: Bengt Herweg MD, Arzu Ilercil MD, Eric Harrison MD

    This is a prospective, multicenter, clinical study designed to compare drug therapy and catheter ablation in patients with atrial fibrillation. This study will help decide which treatment approach is best or when one or the other therapy is preferred. The CABANA study will also compare the cost of care for the two treatment approaches and determine the effect these therapies have on quality of life.

     

  3. July 2010-Current DE-MRI Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation (DECAAF)
  4. Investigator-Initiated

    Investigators: Bengt Herweg MD, Arzu Ilercil MD, Eric Harrison MD

    The purpose of this study is to see if the information collected during an MRI (use of a magnetic field to produce an image) of the heart can also determine the stage of atrial fibrillation and to see if it can predict the outcome of the ablation procedure.

     

  5. Nov 2010-Current QuickFlex® µ 1258T Left Heart Pacing Lead Post Approval Study
  6. Sponsored by St Jude Medical

    Investigators: Bengt Herweg MD, Dany Sayad MD

    The purpose of this study is to collect additional information on the safety and long term performance of the QuickFlex®µ Model 1258T left ventricular (LV) lead. This LV lead is approved by the Food and Drug Administration (FDA).

     

  7. Mar 2011-Current Irrigated Ablation System Evaluation for AF (IRASE AF)
  8. Sponsored by St. Jude Medical

    Investigators: Bengt Herweg MD, Arzu Ilercil MD

    The purpose of this research study is to test the safety and effectiveness of the Safire BLU Duo Cardiac Ablation System for the treatment of Atrial Fibrillation. The Safire BLU Duo Cardiac Ablation System (study device) has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of atrial fibrillation. This study will gather information about the effectiveness of the study device and about risks of using it. Information from this study will be used to obtain FDA approval.

     

  9. Jan 2012-Current Clinical Evaluation of Therapy TM Cool Flex™ Irrigated Ablation Catheter System For the Treatment of Typical Atrial Flutter (FLEXION-AFL)
  10. Sponsored by St. Jude Medical

    Investigators: Bengt Herweg MD, Arzu Ilercil MD, Sanders Chae MD

    This will be a prospective, multi-center and non-randomized study. The purpose of this research study is to establish the safety and effectiveness of an experimental ablation catheter, called TherapyTM Cool FlexTM, for the treatment of typical atrial flutter. This device has not been approved by the U.S. Food and Drug Administration (FDA).

     

  11. Aug 2012-Current EchoCRT: Echocardiography Guided Cardiac Resynchronization Therapy
  12. Sponsored by Biotronik

    Investigators: Bengt Herweg MD, Debbie A Rinde-Hoffman MD, Siva Kumar MD, Peter Berman MD, Gillermo Cintron MD, Mark Weston MD, Arzu Ilercil MD, Dany Sayad MD, Luis Arroyo MD

    The purpose of this study is to find out if CRT can prevent death or reduce Heart Failure hospitalizations for subjects who show dyssynchrony on an Echocardiogram, but don’t show it on an ECG. Although the device and leads used in this study are FDA-approved, this is an investigational study because CRT is being evaluated for its possible benefit in a new group of people with Heart Failure rather than people for whom it is approved.

     

  13. Pending Approval NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent Symptomatic Paroxysmal AF Population
  14. Sponsored by Biosense Webster

    Investigators: Bengt Herweg MD, Arzu Ilercil MD, Sanders Chae MD

    This is a prospective, multi-center, clinical study designed to measure the “real-world” acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in in subjects with drug refractory, symptomatic paroxysmal AF.

     

  15. Pending Approval Accent MRI™ Pacemaker and Tendril MRI™ Lead IDE Study
  16. Sponsored by St. Jude Medical 

    Investigators: Bengt Herweg MD, Sanders Chae MD, Dany Sayad MD, LeelaKrishna Nallamshetty MD

    This is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.

     

  17. Pending Approval Attain PerformaTM Quadripolar Lead Clinical Study
  18. Sponsored by Medtronic

    Investigators: Bengt Herweg MD, Sanders Chae MD, Dany Sayad MD

    The purpose of this clinical study is to assess the safety and effectiveness of the Medtronic Attain Performa quadripolar, left ventricular pacing lead.