Clinical trials: Injury Prevention
Proliferative Vitreoretinopathy
The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
The GUARD Trial is a multi-center, randomized, controlled, adaptive Phase 3 clinical trial of repeated intravitreal injections of ADX-2191 versus standard-of-care for the prevention of proliferative vitreoretinopathy.
- Trial name
- NCT04136366
- Testing
- ADX-2191 (intravitreal methotrexate 0.8%), Standard surgical care procedure
- Where
- 23 sites in United States
- Volunteers
- 106 people
- Sponsor
- Aldeyra Therapeutics, Inc.
Pulmonary Embolism, Deep Vein Thrombosis
Angel® Catheter Early Feasibility Clinical Study
The primary objective of this clinical trial is to obtain initial insights into the safety of the Angel® Catheter in critically ill subjects with high risk of venous thromboembolism (VTE) disease AND who are not receiving…
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism
- Trial name
- NCT01847196
- Testing
- Angel® Catheter
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- BiO2 Medical
Gum Injury
Assessing Effects of a Denture Gel on Gum Abrasions
This is a parallel design study. Up to 40 subjects with a full mandibular and full maxillary dentures will be enrolled into the study. Subjects will use their current denture care +/- a treatment gel for 4 weeks.
- Trial name
- NCT04913636
- Testing
- Treatment Gel
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Procter and Gamble
Surgical Site Infection
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
- Trial name
- NCT02255487
- Testing
- IrriSept System, No Intervention - Standard of Care (SoC) only
- Where
- 17 sites in United States
- Volunteers
- 627 people
- Sponsor
- Irrimax Corporation
Pressure Injury Prevention
Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk
A post market clinical follow-up study investigating the safety of Biatain Silicone Sacral while used as prevention in hospital admitted patients at risk of developing a pressure injury.
- Trial name
- NCT05619003
- Testing
- Biatain Silicone Sacral dressing
- Where
- 3 sites in Denmark
- Volunteers
- 67 people
- Sponsor
- Coloplast A/S
Osteoporosis, Postmenopausal Osteoporosis
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.
- Trial name
- ACTIVE (NCT01343004)
- Testing
- BA058 80 mcg, teriparatide
- Where
- 28 sites in United States, Argentina and 8 more
- Volunteers
- 2,463 people
- Sponsor
- Radius Health, Inc.
Cerebrospinal Fluid Leaks
TASALL - TachoSil® Against Liquor Leak
The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively.
- Trial name
- NCT01355627
- Testing
- TachoSil®, Current Practice
- Where
- 39 sites in Austria, Belgium and 9 more
- Volunteers
- 726 people
- Sponsor
- Takeda
Wound Contamination, Colorectal Surgery
Cleancision IntRaoperative Contamination prEvention Study
This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is…
- Trial name
- CIRCE (NCT02413879)
- Testing
- CleanCision
- Where
- 7 sites in United States
- Volunteers
- 108 people
- Sponsor
- Prescient Surgical
Surgical Site Infection, Colon Surgery
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- NCT04233424
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 62 sites in United States, Bulgaria and 8 more
- Volunteers
- 977 people
- Sponsor
- PolyPid Ltd.
Atrial Fibrillation, AFib
Stroke Feasibility Study
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage.
- Trial name
- NCT01997905
- Testing
- AtriClip LAA Exclusion Device
- Where
- 7 sites in United States
- Volunteers
- 13 people
- Sponsor
- AtriCure, Inc.
Surgical Site Infection
Air Barrier System for the Prevention of Surgical Site Infection
Airborne particles are present in all indoor environments including the operating room. Most of these particles come from the surgical staff moving around in the room, positioning of the patient during surgery, and the movement…
- Trial name
- ABS (NCT01610271)
- Testing
- Air Barrier System
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Nimbic Systems, LLC
COVID, Severe Acute Respiratory Syndrome
LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy…
- Conditions
- COVID, Severe Acute Respiratory Syndrome, Sars-CoV2, Acute Kidney Injury
- Trial name
- NCT04402957
- Testing
- LSALT peptide
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 61 people
- Sponsor
- Arch Biopartners Inc.
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Delayed Healing
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery…
- Trial name
- NCT01640366
- Testing
- PICO
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 200 people
- Sponsor
- Smith & Nephew, Inc.
Human Immunodeficiency Virus (HIV)
Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
The primary purpose of this study is to assess the rate of early discontinuation from randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason other than confirmation of the negative HIV…
- Trial name
- PEPDar (NCT01516970)
- Testing
- Darunavir/Ritonavir (DRV/r), Lopinavir in fixed combination with Ritonavir, Zidovudine
- Where
- 17 sites in Germany
- Volunteers
- 312 people
- Sponsor
- Janssen-Cilag G.m.b.H
Ischemia-Reperfusion Injury, Kidney Diseases
Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation
The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8.
- Trial name
- NCT00248040
- Testing
- Reparixin continuous infusion, reparixin intermittent infusion
- Where
- 9 sites in United States, France and 2 more
- Volunteers
- 80 people
- Sponsor
- Dompé Farmaceutici S.p.A
Ischemia-Reperfusion Injury, Lung Transplantation
Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
The objective of this clinical study was to evaluate whether CXCL8 (CXC ligand 8 [formerly interleukin (IL)-8]) inhibition with repertaxin leads to reduced severity of primary graft dysfunction, as the result of improved…
- Trial name
- NCT00224406
- Testing
- Repertaxin
- Where
- 6 sites in United States, Canada
- Volunteers
- 114 people
- Sponsor
- Dompé Farmaceutici S.p.A
ICU Acquired Weakness
Evaluation of FDY-5301 in Major Trauma Patients in ICU
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit acquired weakness (ICUAW)
- Trial name
- NCT04430283
- Testing
- FDY-5301
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Faraday Pharmaceuticals, Inc.
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Thrombosis, Venous
A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by…
- Trial name
- FONDACAST (NCT00843492)
- Testing
- Fondaparinux sodium, Nadroparin
- Where
- 122 sites in France, Germany and 4 more
- Volunteers
- 1,351 people
- Sponsor
- GlaxoSmithKline