Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This project is an evaluation of a novel device, the Air Barrier System (ABS), to reduce the risk of prosthesis-related surgical site infection in a multi-center clinical trial. The ABS shields surgical incisions intra-operatively by creating a field of high-purity air surrounding an incision that prevents airborne microorganisms from entering the incision.
This research will evaluate ABS performance in a prospective, randomized, blinded multi-center trial. The surgical procedures studied will include total hip arthroplasty, trauma-related acetabula reconstruction, posterior instrumented spine fusion, and prosthetic vascular graft procedures. Patients will be enrolled during the first two years of the study, and CDC guidelines require a one year follow-up period to monitor patients for potential prosthesis-related infections.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABS deployed and active | Experimental | Air Barrier System (ABS) will be deployed onto the surgical field and activated. |
|
| ABS deployed and NOT active | Sham Comparator | Air Barrier System (ABS) will be deployed onto the surgical field and NOT activated. This is a sham comparator to reduce the influence of the presence of the device and provide user blinding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABS deployed and active | Device | ABS is deployed onto surgical field and is turned on. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical incidence of surgical site infection | Subjects are followed for one year post-surgery for onset of prosthesis-related infections . | One-year post surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Self | Contact | 281-565-5715 | self@nimbicsystems.com | |
| Kylie Pflieger | Contact | 281-565-5701 | k.pflieger@nimbicsystems.com |
| Name | Affiliation | Role |
|---|---|---|
| Sean Self | Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center | Recruiting | Houston | Texas | 77030 | United States |
There is no current plan.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016459 | Prosthesis-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ABS deployed and NOT active | Device | ABS is deployed onto surgical field and is NOT turned on. |
|