Impact of V.A.C. Veraflo Therapy in Wounds Requiring Debridement Within an Orthopedic Practice

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.

Inclusion Criteria:

- Signed Informed Consent.

- Patients requiring surgical debridement for wounds with exposed hardware and/or bone,
traumatic wounds, dehisced wounds, post-surgical wounds, and pressure ulcers/sores
requiring debridement.

- Age: 18 years and above.

- Gender: Male or Female.

- No use of Investigational Agents/Devices on study or within 30 days prior to
enrollment.

- Subjects who will be locally available for the next 6 months.

Exclusion Criteria:

- Wounds involving prosthetic joints.

- Patients who are unable to adhere to scheduled study visits.