V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected W… (NCT02009501) | Clinical Trial Compass
CompletedNot Applicable
V.A.C. VeraFloâ„¢ Instillation Therapy vs V.A.C. Ultaâ„¢ Therapy on Biofilm in Chronically Infected Wounds
United States20 participantsStarted 2013-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
What they're measuring
1
Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers