Clinical trials: Surgical Site Infection
Degenerative Disc Disease (DDD), Spinal Stenosis
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems…
- Conditions
- Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities
- Trial name
- INFO SPINE (NCT07615491)
- Testing
- Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK), Titania® Posterior Cervical Stabilization System
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 561 people
- Sponsor
- Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
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
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
Staphylococcal Skin Infections, Diabetic Foot Infections
A Complicated Skin and Soft-tissue Infection Patient Registry
The purpose of this registry is to better understand (1) complicated skin and soft-tissue infections requiring hospitalization, and (2) clinical and economic outcomes in hospitalized patients receiving intravenous antibiotic…
- Conditions
- Staphylococcal Skin Infections, Diabetic Foot Infections, Surgical Wound Infection, Abscess
- Trial name
- NCT00737269
- Volunteers
- 1,081 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
Surgical Wound Infection, Traumatic Wound Infection
A Study of Amicidin-β Topical Solution for Patients With a Contaminated or Infected Surgical or Traumatic Wound or Cutaneous Abscess
The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into contaminated or infected surgical or traumatic wounds or cutaneous abscess during a surgical…
- Conditions
- Surgical Wound Infection, Traumatic Wound Infection, Cutaneous Abscess
- Trial name
- NCT07379684
- Testing
- Amicidin-β topical solution - 15 mL, Amicidin-β topical solution - 50 mL, Standard of Care (SOC)
- Where
- 5 sites in United States
- Volunteers
- 44 people
- Sponsor
- Macro Biologics, Inc.
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.
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.
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
Infections
Study to Evaluate Efficacy and Safety of E-101 Solution for Preventing Surgical Site Infections After Colorectal Surgery
This study is intended to determine the efficacy, safety and tolerability of topical application of E-101 Solution directly into the surgical incisional wound in the prevention of infection of superficial and deep surgical…
- Trial name
- Triple IN (NCT01297959)
- Testing
- E-101 Solution 300 GU/ml, Saline solution
- Where
- 39 sites in United States, Israel
- Volunteers
- 503 people
- Sponsor
- Excited States, LLC
Surgical Site Infection, Staphylococcus Aureus Infection
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
DUOFAG® is a phage cocktail containing bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa. It is an investigational medicinal product for the treatment of surgical site infections caused by S.
- Conditions
- Surgical Site Infection, Staphylococcus Aureus Infection, Pseudomonas Aeruginosa Infection, Bacterial Infections
- Trial name
- NCT06319235
- Testing
- IMP
- Where
- Czechia
- Volunteers
- 52 people
- Sponsor
- MB PHARMA s.r.o.
Diabetic Foot Ulcer, Venous Leg Ulcer
PLASOMA Ultimate Safety & Efficacy Study
The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound
- Trial name
- PULSE (NCT04828304)
- Testing
- PLASOMA
- Where
- 6 sites in Netherlands
- Volunteers
- 101 people
- Sponsor
- Plasmacure
Colorectal Surgery, Surgical Wound Infection
A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery.
- Trial name
- NCT00600925
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 39 sites in United States
- Volunteers
- 602 people
- Sponsor
- Innocoll
Surgical Site Infections, Surgical Wound Infection
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major…
- Conditions
- Surgical Site Infections, Surgical Wound Infection, Infections, Anti-Infective Agents
- Trial name
- LANTERN (NCT06702878)
- Testing
- nasal antimicrobial photodisinfection therapy
- Where
- 14 sites in United States
- Volunteers
- 4,787 people
- Sponsor
- Ondine Biomedical Inc.
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
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
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
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
Abscess, Wound Infection
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a…
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Trial name
- NCT01339091
- Testing
- Dalbavancin, Vancomycin / Linezolid
- Where
- 91 sites in United States, Canada and 6 more
- Volunteers
- 573 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc