Clinical trials: Postoperative Surgical Site Infections
Surgical Site Infection
Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™
The purpose of this pilot study is to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied in two different areas when used as a patient preoperative skin preparation.
- Trial name
- ZX-ZP-0035 (NCT02221232)
- Testing
- Chloraprep, ZuraPrep, ZuraPrep Vehicle
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Zurex Pharma, 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.
Surgical Site Infection
Impact of Pre-surgical Nasal Bacterial Reduction on Postoperative Surgical Site Infections / Standard Care Change
Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent…
- Trial name
- NCT01148030
- Testing
- 3M Skin and Nasal Antiseptic
- Where
- United States
- Volunteers
- 333 people
- Sponsor
- 3M
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 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.
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
- NCT01431339
- Testing
- IV Dalbavancin, Vancomycin/Linezolid
- Where
- 137 sites in United States, Bulgaria and 12 more
- Volunteers
- 739 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
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, 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.
Surgical Site Infections, Nosocomial Infection
Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures
This is a Phase 2 single-center, open-label, single-arm, study of a microbiological endpoint using antimicrobial photodynamic therapy (aPDT) for nasal disinfection in all patients (universal) presenting for surgery at an acute…
- Conditions
- Surgical Site Infections, Nosocomial Infection, Healthcare Associated Infections
- Trial name
- BENEFIT-PDT (NCT05090657)
- Testing
- methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation
- Where
- United States
- Volunteers
- 322 people
- Sponsor
- Ondine Biomedical Inc.
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
- NCT00423657
- Testing
- ceftaroline, vancomycin plus aztreonam
- Where
- 54 sites in United States, Argentina and 10 more
- Volunteers
- 680 people
- Sponsor
- Forest Laboratories
Surgical Wound Infection
Clinical Assessment of Next Science Solution on Gustilo and Anderson Type II and IIIA or IIIB Tibial Fractures
This is a prospective, randomized, controlled, double-blinded clinical feasibility study of subjects that are being treated for Gustilo and Anderson Type II or IIIA or IIIB Tibial Fractures
- Trial name
- NCT04906642
- Testing
- Next Science, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Next Science TM
Surgical Site Infection
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression.
- Trial name
- NCT01313182
- Testing
- mupirocin calcium ointment, 2%, 3M Skin and Nasal Antiseptic
- Where
- United States
- Volunteers
- 1,874 people
- Sponsor
- Solventum US LLC
Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site Infection
Surgicel NU-KNIT Vs Bone Wax on Median Sternotomy
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier.
- Trial name
- NBCS (NCT06869772)
- Testing
- Closure of sternotomy
- Where
- Qatar
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hamad Medical Corporation
Fractures, Open, Fractures, Closed
LOQTEQ® Antibacterial Pre-Market Study
aap001 is a randomized, controlled, subject-blinded, multi-center study to show the safety of the LOQTEQ® antibacterial silver-coated system is non-inferior in comparison with the uncoated LOQTEQ® system
- Conditions
- Fractures, Open, Fractures, Closed, Surgical Site Infection, Fracture of Fibula
- Trial name
- NCT05260463
- Testing
- Implantation
- Where
- 13 sites in Germany
- Volunteers
- 203 people
- Sponsor
- aap Implantate AG
Surgical Site Infection
Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle
ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties.
- Trial name
- NCT02578771
- Testing
- ZuraPrep with 70% IPA, ZuraPrep without 70% IPA, ChloraPrep CHG/IPA Teal Tint
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Zurex Pharma, Inc.
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
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
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
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
Surgical Site Infections, Infections
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections - Canada
This is a Phase 4 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, Infections, Surgical Wound Infections, Anti-Infective Agents
- Trial name
- LANTERN (NCT07189858)
- Testing
- Nasal antimicrobial photodisinfection therapy
- Where
- 4 sites in Canada
- Volunteers
- 401 people
- Sponsor
- Ondine Biomedical Inc.