Clinical trials: Surgical Wound
Wounds and Injuries
Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chronic wounds with different etiologies…
- Trial name
- NCT00552643
- Testing
- Suspension of polystyrene beads (POLYHEAL 1), Saline (0.9% NaCl)
- Where
- 6 sites in Israel
- Volunteers
- 60 people
- Sponsor
- Polyheal Ltd.
Wound Heal
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs…
- Trial name
- MOSAIC (NCT06600152)
- Testing
- MAP Wound Matrix, DuoDerm
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tempo Therapeutics
Recurrent Cubital Tunnel Syndrome, Recalcitrant Cubital Tunnel Syndrome
Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression
This single-cohort, prospective case series is designed to evaluate and characterize the use of Axoguard HA+ Nerve Protector™ to protect the ulnar nerve in a first revision cubital tunnel decompression procedure.
- Trial name
- COVERED (NCT06117501)
- Testing
- Axoguard HA+ Nerve Protector™
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Axogen Corporation
Surgical Wound
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
- Trial name
- Closer (NCT02136004)
- Testing
- Closer VSS
- Where
- 12 sites in United States
- Volunteers
- 220 people
- Sponsor
- Rex Medical
Wound Healing and Prevention
Performance, Safety and Efficacy of NPWT Device
Smith \& Nephew are assessing a new investigational single use NPWT system.
- Trial name
- NCT04102865
- Testing
- Negative-Pressure Wound Therapy (NPWT)
- Where
- 8 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Smith & Nephew, Inc.
Linear or Emi-linear Incisions, Total Hip Arthroplasty
Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty
The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.
- Conditions
- Linear or Emi-linear Incisions, Total Hip Arthroplasty, Total Knee Arthroplasty
- Trial name
- Prevena2009-45 (NCT01380665)
- Testing
- Prevena Incisional Management System
- Sponsor
- KCI USA, Inc
Wounds and Injuries
ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study
Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional…
- Trial name
- ZIPS3 (NCT03201536)
- Testing
- conventional Suture, Zip3
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- ZipLine Medical Inc.
Tibial Plateau Fracture
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
This study will compare two approaches to rehabilitation after surgery for a fracture of the upper part of the shinbone that involves the knee joint (tibial plateau fracture).
- Trial name
- NCT07897149
- Testing
- Crutch Tip Biofeedback System, Individualized FEA-Guided Postoperative Weight-Bearing, Usual-Care Postoperative Weight-Bearing
- Volunteers
- 86 people
- Sponsor
- Comeback Mobility Inc
Hip Fractures
Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery
The purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.
- Trial name
- NCT00685958
- Testing
- enoxaparin (XRP4563)
- Where
- Japan
- Volunteers
- 54 people
- Sponsor
- Sanofi
Chronic Kidney Disease, CKD
ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who…
- Conditions
- Chronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary Bypass
- Trial name
- ARTEMIS (NCT05746559)
- Testing
- Ravulizumab
- Where
- 130 sites in United States, Argentina and 18 more
- Volunteers
- 555 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cardiac Surgery Associated - Acute Kidney Injury
Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery
The is a two-stage study. Stage 1 is to evaluate the safety, tolerability, PK and PD of ENN0403 in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass.
- Trial name
- NCT06632613
- Testing
- ENN0403 capsules, low dose, ENN0403 capsules, high dose
- Where
- China
- Volunteers
- 200 people
- Sponsor
- EnnovaBio
Surgical Site Infections
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
This is a randomized, blinded, placebo and standard of care controlled study of the efficacy of a novel antibiotic containing gel compared to placebo gel in preventing surgical site infection after abdominal surgery.
- Trial name
- NCT01888367
- Testing
- DFA-02 Antibiotic Gel
- Where
- 31 sites in United States
- Volunteers
- 445 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Neuralgia
P4 (Pregabalin for Peripheral Posttraumatic Pain)
To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain
- Trial name
- P4 (NCT00292188)
- Testing
- pregabalin
- Where
- 44 sites in Belgium, Canada and 9 more
- Volunteers
- 255 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypothermia
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers.
- Trial name
- NCT02177903
- Testing
- Bair Paws Patient Adjustable Warming System
- Where
- Canada
- Volunteers
- 220 people
- Sponsor
- Solventum US LLC
Post Surgical Incisions From Abdominoplasty Procedures
Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.
- Trial name
- Mona Lisa (NCT00766727)
- Testing
- GLYDe Dressing
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neodyne Biosciences, Inc.
Cerebrospinal Fluid Leakage
Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair
Study in which the presence or absence of symptoms or any health condition is observed and recorded 30 days after a cranial surgery in which the physician places a material or graft, either BIOSCAFF®H or DuraGen®, into the skull…
- Trial name
- NCT06419855
- Testing
- Human collagen matrix graft, Bovine collagen matrix graft
- Where
- 4 sites in Mexico
- Volunteers
- 2 people
- Sponsor
- Top Health S.A.P.I DE C.V.
Bacterial Infections
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
- Trial name
- cSSSI (NCT00424190)
- Testing
- IV Vancomycin plus IV Aztreonam, Ceftaroline
- Where
- 52 sites in United States, Argentina and 9 more
- Volunteers
- 698 people
- Sponsor
- Forest Laboratories
Hip Osteoarthritis, Avascular Necrosis
Insignia™ Hip Stem Outcomes Study
The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.
- Conditions
- Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis
- Trial name
- NCT05144191
- Testing
- Insignia uncemented Hip Stem
- Where
- 11 sites in United States
- Volunteers
- 313 people
- Sponsor
- Stryker Orthopaedics
Staphylococcus Aureus, Orthopaedic Surgery
Preoperative Decolonization and Surgical Site Infections in Orthopaedic Surgery - 2 Year Outcome in Prosthetic Surgery
Surgical site infections in orthopaedic surgery are a major problem. Decolonization has been suggested to reduce infection rates.
- Conditions
- Staphylococcus Aureus, Orthopaedic Surgery, Surgical Site Infection, Prevention
- Trial name
- DECO-SSI (NCT03962907)
- Testing
- Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun, BACTROBAN® Nasal ong
- Where
- Switzerland
- Volunteers
- 1,318 people
- Sponsor
- Lindenhofgruppe AG
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.