Clinical trials: Wound Infection
Acute Kidney Injury Due to Sepsis
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a…
- Trial name
- NCT05507437
- Testing
- TIN816 70 mg lyophilisate powder
- Where
- 7 sites in Belgium, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Abscess
The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)
The purpose of this study was to evaluate the safety and effectiveness of Irrisept compared to standard of care treatment of skin and soft tissue infections in the form of abscesses.
- Trial name
- NCT04957732
- Testing
- Standard of Care (SoC), Irrisept Delivery System
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Irrimax Corporation
Bacterial Infection
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware.
- Trial name
- NCT02436876
- Testing
- MBN-101
- Where
- 6 sites in United States
- Volunteers
- 29 people
- Sponsor
- Microbion Corporation
Surgical Site Occurences After Sternotomy, Wound Infection
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy).
- Trial name
- NCT02195310
- Testing
- Prevena™ Incision Management System, Conventional sterile wound dressings
- Where
- 13 sites in Austria, Germany and 1 more
- Volunteers
- 342 people
- Sponsor
- Solventum US LLC
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.
Degenerative Sacroiliitis, Sacroiliac Joint Disruption
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint).
- Trial name
- SIFI (NCT01640353)
- Where
- 26 sites in United States
- Volunteers
- 194 people
- Sponsor
- SI-BONE, Inc.
Surgical Site Infection
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
- Trial name
- NCT02255487
- Testing
- IrriSept System, No Intervention - Standard of Care (SoC) only
- Where
- 17 sites in United States
- Volunteers
- 627 people
- Sponsor
- Irrimax Corporation
Renal Insufficiency, Acute, Renal Insufficiency, Chronic
Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal Insufficiency
This is a Phase 1, open-label, single-dose study of the safety, tolerability, and pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal insufficiency.
- Conditions
- Renal Insufficiency, Acute, Renal Insufficiency, Chronic, Healthy Subjects
- Trial name
- NCT02808052
- Testing
- Minocin (minocycline) for Injection
- Where
- Germany
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Wound Infection, Abscess
Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection
The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic benefit of oritavancin administered as a…
- Conditions
- Wound Infection, Abscess, Systemic Inflammation, Cellulitis
- Trial name
- SOLO II (NCT01252732)
- Testing
- Single-Dose IV Oritavancin Diphosphate, IV Vancomycin
- Where
- United States
- Volunteers
- 1,019 people
- Sponsor
- Melinta Therapeutics, Inc.
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
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
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
Acute Kidney Injury, Peritonitis
Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.
- Conditions
- Acute Kidney Injury, Peritonitis, Necrotizing Soft Tissue Infection
- Trial name
- NCT03403751
- Testing
- Reltecimod 0.5 mg/kg
- Where
- 56 sites in United States, France
- Volunteers
- 58 people
- Sponsor
- Atox Bio Ltd
Invasive Candidiasis, Candidemia
Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
The purpose of this study is to estimate the relative risk of severe hepatic injury in hospitalized patients with invasive candidiasis and candidemia who received anidulafungin, compared to patients who received caspofungin…
- Trial name
- NCT01213823
- Testing
- Does not apply
- Volunteers
- 536 people, healthy volunteers welcome
- Sponsor
- Pfizer
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.
Complicated Skin and Soft Tissue Infection
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.
- Trial name
- NCT01499277
- Testing
- Ceftaroline fosamil, Vancomycin, Aztreonam
- Where
- 91 sites in United States, Argentina and 26 more
- Volunteers
- 802 people
- Sponsor
- Pfizer
Wound Infection, Abscess
Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant…
- Conditions
- Wound Infection, Abscess, Systemic Inflammation, Cellulitis
- Trial name
- SOLO I (NCT01252719)
- Testing
- Single-Dose IV Oritavancin Diphosphate, IV Vancomycin
- Where
- United States
- Volunteers
- 968 people
- Sponsor
- Melinta Therapeutics, 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
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
Coronavirus Disease 2019 (COVID-19), Acute Lung Injury
Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure
This was a randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of dociparstat sodium in adult patients with acute lung injury (ALI) due to Coronavirus Disease 2019 (COVID-19).
- Conditions
- Coronavirus Disease 2019 (COVID-19), Acute Lung Injury, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Trial name
- NCT04389840
- Testing
- Dociparstat sodium
- Where
- 12 sites in United States
- Volunteers
- 27 people
- Sponsor
- Jazz Pharmaceuticals