A Prospective, Open, Comparative, Randomized Single-center Study to Evaluate the Effect of V.A.C. VeraFlo™ Therapy With .125% Dakins vs V.A.C. Ulta™ Therapy on Biofilm Removal/Disruption/Elimination in Chronically Infected Wounds

St. Luke's-Roosevelt Hospital Center1 site in 1 country20 target enrollmentNovember 2013

ConditionsLower Extremity Wound Infected Venous Stasis Ulcers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lower Extremity Wound Infected
Sponsor: St. Luke's-Roosevelt Hospital Center
Enrollment: 20
Locations: 1
Primary Endpoint: Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

June 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

St. Luke's-Roosevelt Hospital Center

Responsible Party

Sponsor

Eligibility Criteria

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.

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.