Clinical trials: Surgical Infection
Cataract
Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery
To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.
- Trial name
- NCT00870103
- Testing
- Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Alcon Research
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.
Ethmoid Sinusitis, Rhinosinusitis
Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel
The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel, a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery.
- Trial name
- NCT00554190
- Testing
- AdvaCoat sinus gel, Merogel Injectable
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- Carbylan Therapeutics, 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
- 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
Inflammation and Pain Following Ocular Surgery
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.
- Trial name
- NCT02065375
- Testing
- Omaveloxolone Ophthalmic Suspension 1.0%, Omaveloxolone Opthalmic Suspension 0.5%
- Where
- 6 sites in United States
- Volunteers
- 109 people
- Sponsor
- Biogen
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
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
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
Chronic Sinusitis
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.
- Trial name
- NCT00231062
- Testing
- Sinuplasty
- Volunteers
- 115 people
- Sponsor
- Integra LifeSciences Corporation
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, Sternal Wound Infection
Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal…
- Trial name
- NCT00600483
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 43 sites in United States
- Volunteers
- 1,502 people
- Sponsor
- Innocoll
Postoperative Infection
Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects
This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery.
- Trial name
- NCT03231228
- Testing
- Cefazolin 1 g Infusion, Cefazolin 2 g Infusion
- Where
- 5 sites in United States
- Volunteers
- 61 people
- Sponsor
- B. Braun Medical 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
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
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above…
- Trial name
- NCT02731573
- Testing
- D-PLEX, Open heart surgery
- Where
- 5 sites in Israel
- Volunteers
- 81 people
- Sponsor
- PolyPid Ltd.
Surgical Site Infection
Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances
Comparative study of antimicrobial effectiveness evaluation of of 26ml Project X, 10.5ml Project X, 5.1ml Project X and Prevantics Maxi swabstick following ASTM E1173 - Standard test method for evaluation of preoperative…
- Trial name
- NCT04218110
- Testing
- Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic, Prevantics 3.15 % / 70 % Swabstick
- Where
- Romania
- Volunteers
- 329 people, healthy volunteers welcome
- Sponsor
- Professional Disposables International, Inc.
Breast Cancer
Coated VICRYL* Plus Suture Compared to Chinese Silk in Scheduled Breast Cancer Surgery
This is a 90-day study to evaluate cosmetic outcome and Surgical Site Infection in approximately 100 patients from 6 centers in China undergoing scheduled modified radical mastectomy for breast cancer.
- Trial name
- NCT00768222
- Testing
- silk suture, VICRYL* Plus suture
- Where
- 6 sites in China
- Volunteers
- 101 people
- Sponsor
- Ethicon, 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
- 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