Clinical trials: Surgical Infection
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.
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.
Rhinosinusitis
Healthcare Utilization and Outcomes of FinESS Treatment in the Office
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
- Trial name
- RELIEF (NCT00986830)
- Testing
- FinESS Sinus Treatment
- Where
- 13 sites in United States
- Volunteers
- 74 people
- Sponsor
- Entellus Medical, Inc.
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
Acute Otitis Media
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.
- Trial name
- NCT00578773
- Testing
- Moxidex otic solution, Moxifloxacin otic solution, Tympanostomy tubes
- Volunteers
- 303 people
- Sponsor
- Alcon Research
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
Arthritis, Traumatic Arthritis
Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty
The goal of this randomized, controlled, monocentric, single-blind, 2-arm, feasibility clinical investigation is to evaluate the safety of MectaShield hydrogel coating and to capture its preliminary clinical performance in the…
- Conditions
- Arthritis, Traumatic Arthritis, Avascular Necrosis
- Trial name
- NCT05679232
- Testing
- Hydrogel coating, Control
- Where
- Austria
- Volunteers
- 56 people
- Sponsor
- Medacta International SA
Staphylococcal Infections
StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery
Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections associated with orthopedic surgery. StaphVAX® is a bivalent S.
- Trial name
- NCT00211965
- Testing
- S. aureus Types 5 and 8 Capsular Polysaccharide Conjugate
- Where
- United Kingdom
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Nabi Biopharmaceuticals
Sinusitis
Hemostatic Matrix in Endoscopic Sinus Surgery
Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving hemostasis in patients undergoing endoscopic sinus surgery.
- Trial name
- NCT00242437
- Testing
- Hemostatic matrix, bovine thrombin
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ethicon, Inc.
Staphylococcus Aureus, Bacteremia
Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)
This study will assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery.
- Conditions
- Staphylococcus Aureus, Bacteremia, Mediastinitis
- Trial name
- NCT00518687
- Testing
- V710
- Volunteers
- 8,031 people
- Sponsor
- Merck Sharp & Dohme LLC
Degenerative Disc Disease, Spinal Stenosis
Burst Biologics Spinal Fusion Registry
A multicenter patient registry was created with aim of documenting how spine and neurosurgeons are utilizing Burst Biologics products along with patient outcomes.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylitis, Spondylolisthesis
- Trial name
- NCT03064802
- Testing
- BioBurst Fluid, Burst Allograft
- Where
- 4 sites in United States
- Volunteers
- 450 people
- Sponsor
- Burst Biologics
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.
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
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
Hidradenitis Suppurativa (HS)
Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.
- Trial name
- SHARPS (NCT02808975)
- Testing
- Adalimumab
- Where
- 55 sites in United States, Belgium and 21 more
- Volunteers
- 206 people
- Sponsor
- AbbVie
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