Clinical trials: Surgical Injury
Abdominoplasty
Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage
This study is designed to evaluate the safety and efficacy of the device while reducing the amount of drainage from surgical wounds following large flap surgical procedures, in this case abdominoplasty, as compared to the…
- Trial name
- NCT01526954
- Testing
- TissuGlu Surgical Adhesive
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Cohera Medical, Inc.
Degenerative Disc Disease (DDD), Instabilities
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
- Conditions
- Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity
- Trial name
- NCT05489822
- Testing
- VERTICALE® Cervical System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Silony Medical GmbH
Surgical Wound, Bilateral Total Knee Arthroplasty
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
- Conditions
- Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases
- Trial name
- ENABLE (NCT04712019)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Solventum US LLC
Dural Defect, Cerebrospinal Fluid Leak
Immiseal™ Dural Sealant Post-Market Registry Study
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct…
- Conditions
- Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
- Trial name
- NCT07651826
- Where
- Latvia
- Volunteers
- 85 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Wounds, Leg Ulcers
The AutoloGel™ Post-Market Surveillance (TAPS) Program
AutoloGel™ Post-Market Surveillance Program Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including coagulopathies in patients with wounds to which AutoloGel™ was applied.
- Conditions
- Wounds, Leg Ulcers, Pressure Ulcers, Diabetic Foot Ulcers
- Trial name
- TAPS (NCT00762138)
- Testing
- AutoloGel System
- Where
- 2 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Cytomedix
Critical Illness, Burns
Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria
Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs.
- Conditions
- Critical Illness, Burns, Surgery, Urinary Tract Infections
- Trial name
- CAB (NCT03816384)
- Testing
- Standard of Care, DLC Group, DLCS Group
- Sponsor
- Potrero Medical
Surgical Wound
A Comparative Efficacy and Safety Study Between Two Silver Containing Dressings In Post-Op Wound Healing
Study objective: The objective of this study is to evaluate through clinical criteria the clinical efficacy and safety of BCT Silver Bandage role in obstetrical and gynecological wound healing is as effective and safe as Aquacel®…
- Trial name
- NCT01605968
- Testing
- BCT Silver Bandage, Aquacel® Ag. Dressing
- Where
- Taiwan
- Volunteers
- 38 people
- Sponsor
- Bio-medical Carbon Technology Co., Ltd.
Wounds and Injuries
Comparison of Surgical Incision Complications in Patients Receiving PICO or Standard Care Following Colorectal Surgery
Surgical Site Complications (SSC's) are responsible for increased morbidity in patients undergoing surgery resulting in prolonged length of stay in the hospital while increasing treatment and hospital costs dramatically.
- Trial name
- NCT02883010
- Testing
- PICO Softport V1.6, Standard Care
- Sponsor
- Smith & Nephew, Inc.
Surgical Wound
Clinical Evaluation of a Novel Incisional NPWT System
A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the suitability, safety and efficacy of the system for the management of closed surgical wounds
- Trial name
- NCT04488666
- Testing
- npSIMS
- Where
- New Zealand
- Volunteers
- 23 people
- Sponsor
- Aatru Medical LLC
Postoperative Pain, Hernia
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local…
- Conditions
- Postoperative Pain, Hernia, Surgery
- Trial name
- NCT00974350
- Testing
- SABER-Bupivacaine
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 124 people
- Sponsor
- Durect
Post-operative Complications, Surgical Site Infection
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
- Conditions
- Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
- Trial name
- NCT01450631
- Testing
- Prevena™ Incision Management System (PIMS), Standard-of-care Dressing
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- KCI USA, Inc
Prostate Cancer, Kidney Cancer
DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
Prospective, monocentric, single arm, observational PMCF - Study on the Performance and Safety of Double-Shank Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
- Conditions
- Prostate Cancer, Kidney Cancer, Congenital Abnormality of Kidney, Nephrolithiasis
- Trial name
- DOSTILCU (NCT04869462)
- Where
- Germany
- Volunteers
- 67 people
- Sponsor
- Aesculap AG
Surgical Site Infection
Safety Study to Evaluate the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA
This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human subjects.
- Trial name
- NCT02160574
- Testing
- ChloraPrep, 0.1% Sodium Lauryl Sulfate, 0.9% Physiological Saline
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Zurex Pharma, Inc.
Peripheral Arterial Disease
Multi-center Study for Stent Graft System for Peripheral Artery
The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease.
- Trial name
- VJH11-01 (NCT01575808)
- Testing
- GP1101
- Where
- 15 sites in Japan
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
Bimalleolar Ankle Fractures
CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization.
- Trial name
- NCT02688855
- Testing
- Active Combined Magnetic Field OL1000 Bone Growth Stimulator
- Where
- 9 sites in United States
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Encore Medical, L.P.
Primary Osteoarthritis, Post-Traumatic Arthritis
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Arthritis, Inflammatory Joint Disease, Femoral Neck Fracture
- Trial name
- NCT03357445
- Testing
- Avantage Reload cup
- Where
- 4 sites in France, Slovenia
- Volunteers
- 500 people
- Sponsor
- Zimmer Biomet
Intraoperative Ureter Visualization, Abdominolpelvic Surgery
A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease
The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious.
- Trial name
- NCT05999747
- Testing
- pudexacianinium chloride
- Where
- 12 sites in United States
- Volunteers
- 95 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Orthopedic Disorders, Surgical Site Infection
Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial
Surgical site infections are a major postoperative complication and are mostly due to colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or Propionibacterium acnes.
- Trial name
- DECO-SSI (NCT02560155)
- Testing
- Mupirocin 2% nasal ointement, Chlorhexidine sol 4%
- Where
- Switzerland
- Volunteers
- 1,300 people
- Sponsor
- Lindenhofgruppe AG
Cardiac Surgery, Coronary Artery Bypass Grafting
Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery
The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or…
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Grafting, Valve Surgery, Kidney Injury
- Trial name
- NCT00628264
- Testing
- AP214
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Action Pharma A/S
Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos
Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup
The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
- Conditions
- Primary Osteoarthritis, Post-traumatic Osteoarthritis of Hip Nos, Femur Head Necrosis, Femur Neck Fracture
- Trial name
- NCT02062450
- Testing
- Primary surgery with Dual Mobility Cup, Revision surgery with Dual Mobility Cup
- Volunteers
- 379 people
- Sponsor
- Stryker Trauma and Extremities