V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds

Inclusion criteria

• The patient is of 18 years or older.
• Males and females - provided they are not pregnant and if of reproductive age are using contraception.
• Patient with ulcers that:

• Have an ulcer area of at least 4 cm2 confirmed via counting squares on an wound tracing
• Have been present for at least 4 weeks
• Are confirmed to have a colony forming unit per gram of wound tissue greater than or equal to 10 to the 5th cfu
• Are full thicknesses through to dermal or subcutaneous tissue but not extending to muscle or bone.
• The patient has an ABI of greater or equal to 0.8 and lower than 1.3 or has a suitable Peripheral Vascular Resistance (PVR) and Doppler assessment which confirms venous disease & therefore treatment with Profore is deemed acceptable by the clinician.
• The patient has one or more clinical signs of infection (edema, malodor, local/periwound erythema, spontaneous pain between dressing changes, increased exudate, discoloration of granulation tissue, increased temperature at wound, non progression of wound, purulent exudate and friable granulation tissue)
• The patient is able to understand the evaluation and is willing to consent to the evaluation.
• Patients with a suitable wound on a different limb to any other wounds previously eligible.

Exclusion criteria

• Patients undergoing chemotherapy
• Patients being treated with immunosuppressive drugs or corticosteroids
• Patients with an autoimmune disease
• Patients who have participated in an experimental drug or device study within the last 15 days
• Patients that have been entered in this evaluation previously as an evaluable patient.