Clinical trials: Surgical Wound
Spinal Dural Defect, Cerebrospinal Fluid Leakage
Dural Medical Adhesive for Watertight Sealing in Dural Repair
This is a prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage.
- Conditions
- Spinal Dural Defect, Cerebrospinal Fluid Leakage, Spinal Neurosurgery
- Trial name
- NCT07754344
- Testing
- Dural medical adhesive, Standard dural reinforcement surgery
- Where
- 6 sites in China
- Volunteers
- 141 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Cartilage Injury, Osteochondritis Dissecans
A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.
The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide® collagen membrane either sutured or glued compared to microfracture alone in the treatment of symptomatic cartilage defects of the knee.
- Trial name
- NCT02993510
- Testing
- Microfracture, Chondro-Gide sutured, Chondro-Gide glued
- Where
- 7 sites in Germany
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Geistlich Pharma AG
Renal Insufficiency, Acute Kidney Injury
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing…
- Trial name
- BIPASS-AKI (NCT05990660)
- Testing
- JuxtaFlow System
- Where
- 3 sites in Poland, Serbia
- Volunteers
- 10 people
- Sponsor
- 3ive Labs
Acute Kidney Injury
A Study to Evaluate the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury (AKI) and Major Adverse Kidney Events (MAKE)
The aim of this study is to evaluate the efficacy and safety of GDC-8264 compared with placebo in participants undergoing cardiac surgery who are determined to be at moderate to high risk of developing AKI and subsequent MAKE at…
- Trial name
- NCT06602453
- Testing
- GDC-8264
- Where
- 34 sites in United States, Australia and 10 more
- Volunteers
- 67 people
- Sponsor
- Genentech, Inc.
Tibial Fracture
Assessment of the Verus Frame in Tibial Intramedullary Nailing
This prospective, single-arm Post-Market Clinical Follow-Up (PMCF) study, utilizing a registry-based control group, will assess the Verus frame's effectiveness in achieving precise tibial rotation and alignment during…
- Trial name
- NCT07362121
- Testing
- Verus frame to stabilize tibia
- Where
- Finland
- Volunteers
- 25 people
- Sponsor
- Hemitec Finland Oy
Breast Implant Rupture
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture
This prospective dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture.
- Trial name
- NCT07810205
- Testing
- Silicone Breast Implant Exposure, Prospective Breast Implant Surveillance Imaging
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Pre-surgical Anxiety, Blood Glucose Concentration
Vis Pre Surgery Medical Food Validation Study
A pre-market, confirmatory, prospective, interventional, clinical investigation to confirm the clinical safety and performance profile of Vis Pre-surgeryTM that the medical food will reduce pre and post-surgical complications…
- Conditions
- Pre-surgical Anxiety, Blood Glucose Concentration, Blood Cortisol Levels, Electrolyte Levels
- Trial name
- NCT07359222
- Testing
- Pre-surgical medical food
- Where
- India
- Volunteers
- 67 people
- Sponsor
- TM Nutrition LLC
Complication of Surgical Procedure
TCOT Effectiveness in Preventing Wound Infections in Perineal Resections
In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the surgical site) has been shown to decrease infection rate.
- Trial name
- NCT02374294
- Testing
- Epiflo
- Sponsor
- Neogenix, LLC dba Ogenix
Bone Metastases
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
- Trial name
- NCT00321464
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 2,049 people
- Sponsor
- Amgen
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.
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
Anterior Cruciate Ligament Rupture
Tolerance, Efficacy, revAlidation, Myostim
Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in postoperative revalidation of patients after reconstructive surgery of anterior cruciate ligament.
- Trial name
- NCT04684771
- Testing
- MYOSTIM®
- Where
- 2 sites in Belgium
- Volunteers
- 35 people
- Sponsor
- Alternativa International S.A
Surgical Site Infection
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site…
- Trial name
- DRESS (NCT04042077)
- Testing
- Delafloxacin, Vancomycin, Linezolid
- Where
- Italy
- Volunteers
- 268 people
- Sponsor
- Menarini Group
Coronary Artery Disease
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI.
- Trial name
- NCT02496234
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Sapere Bio
Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement
Review on Minimally Invasive Skin Incision in Vanguard PS Artificial Knee Joint System
This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36…
- Trial name
- NCT01010828
- Testing
- Incision technique
- Where
- Japan
- Volunteers
- 72 people
- Sponsor
- Zimmer Biomet
Surgical Wound, Revision Total Knee Arthroplasty
Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care…
- Conditions
- Surgical Wound, Revision Total Knee Arthroplasty, Wounds and Injuries, Joint Disease
- Trial name
- PROMISES (NCT03274466)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
- Where
- 17 sites in United States
- Volunteers
- 294 people
- Sponsor
- KCI USA, Inc
Cholecystectomy, Benign Hysterectomy
Post Market Study for FloShield 10mm Reusable Cannula and Blunt Obturator and Robotic FloShield
This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery.
- Conditions
- Cholecystectomy, Benign Hysterectomy, Salingo-oophorectomy
- Trial name
- NCT02163239
- Testing
- Cannula and Blunt Obturator
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Minimally Invasive Devices, Inc.
Surgical Wound
LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures
The purpose of this post market study is to evaluate the performance and safety of LiquiBand® Exceed™ and LiquiBand® Rapid™ for closure of surgical incisions associated with abdominal surgery.
- Trial name
- Exceed (NCT04740775)
- Testing
- LiquiBand Exceed, LiquiBand Rapid
- Where
- 4 sites in United States
- Volunteers
- 101 people
- Sponsor
- Advanced Medical Solutions Ltd.
Acute Kidney Injury
Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery.
- Trial name
- AKITA (NCT05126303)
- Testing
- RMC-035
- Where
- 29 sites in United States, Canada and 3 more
- Volunteers
- 177 people
- Sponsor
- Guard Therapeutics AB
Surgical Site Infection
Betadine Versus Saline in Swapping of Subcutaneous Tissue
Caesarean section is an increasingly common major surgical procedure performed on women. Last decade an overall increase of the global rate of caesarean section, of up to 31.2%, was reported.
- Trial name
- NCT06595823
- Testing
- Betadine
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- Egymedicalpedia