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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by St. Luke's-Roosevelt Hospital Center
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT02009501
First received: November 24, 2013
Last updated: July 31, 2014
Last verified: December 2013

November 24, 2013
July 31, 2014
November 2013
November 2014   (final data collection date for primary outcome measure)
Evaluate the change in bacteria colony-forming units using when NPWT and NPWTi on venous leg ulcers [ Time Frame: Baseline through day 7 ] [ Designated as safety issue: No ]
Biopsies for bacteria colony-forming units will be obtained at pre surgical debridement (baseline), post surgical debridement, day 4 and day 7.
Same as current
Complete list of historical versions of study NCT02009501 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
V.A.C. VeraFlo™ Instillation Therapy vs V.A.C. Ulta™ Therapy on Biofilm in Chronically Infected Wounds
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lower Extremity Wound Infected
  • Venous Stasis Ulcers
  • Device: VAC VeraFlo with Dakins Instillation
    VAC VeraFlo with Dakins instillation will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.
    Other Names:
    • NPWTi
    • VAC Instill
  • Device: VAC Ulta Therapy
    VAC ULTA will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.
    Other Names:
    • VAC
    • NPWT
  • Active Comparator: VAC VeraFlo with Dakins Instillation
    VAC VeraFlo with Dakins .125% instillation will be initially applied in the OR after surgical debridement. Dressing will be changed on day 4 and and removed on day 7. Wound assessments will continue at weeks 2, 3, and 4.
    Intervention: Device: VAC VeraFlo with Dakins Instillation
  • Active Comparator: VAC Ulta Therapy
    VAC ULTA Therapy will be initially applied in the OR after surgical debridement. Dressing will be changed on day 4 and and removed on day 7. Wound assessments will continue at weeks 2, 3, and 4.
    Intervention: Device: VAC Ulta Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2014
November 2014   (final data collection date for primary outcome measure)

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:

    1. Have an ulcer area of at least 4 cm2 confirmed via counting squares on an wound tracing
    2. Have been present for at least 4 weeks
    3. Are confirmed to have a colony forming unit per gram of wound tissue greater than or equal to 10 to the 5th cfu
    4. Are full thicknesses through to dermal or subcutaneous tissue but not extending to muscle or bone.
    5. 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.
    6. 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)
    7. The patient is able to understand the evaluation and is willing to consent to the evaluation.
    8. Patients with a suitable wound on a different limb to any other wounds previously eligible.

Exclusion Criteria:

  1. Patients undergoing chemotherapy
  2. Patients being treated with immunosuppressive drugs or corticosteroids
  3. Patients with an autoimmune disease
  4. Patients who have participated in an experimental drug or device study within the last 15 days
  5. Patients that have been entered in this evaluation previously as an evaluable patient.
Both
18 Years and older
No
Contact: Cynthia A Gendics, RN 212-523-2979 cgendics@chpnet.org
Contact: John C Lantis, MD 212-523-4797 jlantis@chpnet.org
United States
 
NCT02009501
VAC/09/05/ULTA
No
St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
Kinetic Concepts, Inc.
Principal Investigator: John C Lantis, MD St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP