Prosthesis-Related Infections Clinical Trial
Official title:
Air Barrier System for the Prevention of Prosthesis-related Infections
This is a prospective, randomized, blinded clinical trial to determine if the Air Barrier System device reduces the incidence of surgical site infection after total hip replacement, acetabular repair, posterior spinal fusion, and prosthetic vascular graft procedures.
Status | Recruiting |
Enrollment | 816 |
Est. completion date | October 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Total hip arthroplasty; - Acetabular repair with instrumentation; - Posterior lumbar, cervical, or thoracic (up to and including 6 vertebral levels) spine fusion with instrumentation and vascular prosthetic graft implantation. Exclusion Criteria: - History of prior prosthesis infection; - Active infection; - Open traumatic wounds as is the case after some acetabular fractures. |
Country | Name | City | State |
---|---|---|---|
United States | Michael E. DeBakey VA Medical Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Nimbic Systems, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical incidence of surgical site infection | Subjects are followed for one year post-surgery for onset of prosthesis-related infections . | One-year post surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01816009 -
Treatment of the Infections on Osteo-articular Prostheses by 6 Versus 12 Weeks of Antibiotherapy
|
Phase 3 | |
Not yet recruiting |
NCT05582460 -
Exploring Novel Diagnostic Tools for Periprosthetic Joint Infection
|
||
Not yet recruiting |
NCT02424903 -
European Prosthetic Joint Infection Cohort Study- Hip, Knee and Shoulder Prosthetic Joint Infection
|
N/A | |
Completed |
NCT02127281 -
Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.
|
N/A | |
Active, not recruiting |
NCT03121183 -
Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers
|
N/A | |
Completed |
NCT04622280 -
Prospectively Observational Evaluation of Clinical Outcomes in Two-stage Revision for Periprosthetic Knee Infection
|
||
Active, not recruiting |
NCT05113303 -
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
|
||
Recruiting |
NCT04304885 -
Effect of Sonication on Periprosthetic Joint Infection Treatment Strategy.
|
||
Not yet recruiting |
NCT06433700 -
Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients
|
||
Recruiting |
NCT04520841 -
Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings
|
N/A | |
Completed |
NCT01760863 -
Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
|
N/A | |
Completed |
NCT06089044 -
Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections
|
||
Recruiting |
NCT03444571 -
PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections
|
N/A | |
Completed |
NCT03274466 -
Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
|
N/A | |
Completed |
NCT02860767 -
Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses
|
N/A | |
Completed |
NCT01175044 -
Dilute Betadine Lavage in the Prevention of Postoperative Infection
|
Phase 4 | |
Active, not recruiting |
NCT00423982 -
Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
|
Phase 4 |