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
| Name | Class |
|---|---|
| Kinetic Concepts, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective to this study is to determine the effectiveness of V.A.C.Veraflo negative pressure wound therapy with instillation, when compared to historical controls of V.A.C Therapy without instillation in the management of wounds.
The V.A.C.Ulta™ Negative Pressure Wound Therapy System is a 510(k) -cleared, Class II device (K100657) with the following indication for use: "the V.A.C.Ulta™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. Negative Pressure Wound Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudates and infectious material. The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The V.A.C.Ulta™ Negative Pressure Wound Therapy System, with and without instillation, is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts". The V.A.C. Ulta™ Therapy Unit is for use with only V.A.C.® Dressings (V.A.C.® GranuFoam™, V.A.C. GranuFoam Silver®, V.A.C. WhiteFoam,® V.A.C. VeraFlo™ Dressing Systems) and disposables. The V.A.C. VeraFlo™ Dressing System is intended for use with V.A.C. VeraFlo™ Therapy as provided by the V.A.C.Ulta™ Therapy Unit. The V.A.C. VeraFlo™ Dressing was cleared under the V.A.C Ulta™ Negative Pressure Wound Therapy System 510(k) (K100657). It is recommended for use with open wounds, including wounds with shallow undermining or tunnel areas where the distal aspect is visible.
Prontosan® Wound Irrigation Solution is a clear, odorless, colorless solution consisting of polyhexamethylene biguanide (PHMB), betaine, sodium hydroxide and purified water. PHMB, also known as Polyhexanide, is a polymer biguanide. PHMB is a cationic preservative which inhibits the growth of microorganisms within the product. Betaine is a zwitterionic (both, negatively and positively charged) surfactant. Prontosan® is a FDA 510(k) cleared device intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post surgical wounds, and abrasions.
The objective to this study is to determine the effectiveness of V.A.C.Veraflo negative pressure wound therapy with Prontosan instillation, when compared to historical controls of V.A.C Therapy without instillation in the management of wounds. We will measure any difference in length of hospital stay, number of days until final surgical procedure, and the number of trips to the or for additional debridement. Patients will be considered infection free when clinical signs of infection are absent and lab values become normal.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPWT with Instillation | Active Comparator | Negative Pressure Wound Therapy with Instillation. |
|
| NPWT without Instillation | Placebo Comparator | Negative Pressure Wound Therapy without Instillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPWT with Instillation | Device | Kinetic Concepts Inc. V.A.C Ulta Negative Pressure Wound Therapy System with V.A.C. VeraFlo Instillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days between the initial and final surgical procedure. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | 6 months | |
| Number of days until wound closure | 6 months | |
| Number of operative debridements |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janet D Conway, MD | Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health | Baltimore | Maryland | 21215 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NPWT | Device | Kinetic Concepts Inc. V.A.C Ulta Negative Pressure Wound Therapy System |
|
| 6 months |
| Recurrence of wound post discharge | 30 days |
| Wound related re-admission | 30 days |