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

Completed · Not applicable

Conditions studied: Lower Extremity Wound Infected, Venous Stasis Ulcers

In brief

This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds.

Key facts

Study ID

NCT02009501

Run by

St. Luke's-Roosevelt Hospital Center

People needed

20

Starts

2013-11-01

Expected to finish

2015-06-01

Last updated by the study team

2018-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Luke's-Roosevelt Hospital Center — New York, New York, United States

Full record on ClinicalTrials.gov

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