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
  Purpose

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.


Condition Intervention
Lower Extremity Wound Infected
Venous Stasis Ulcers
Device: VAC VeraFlo with Dakins Instillation
Device: VAC Ulta Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009501

Contacts
Contact: Cynthia A Gendics, RN 212-523-2979 cgendics@chpnet.org
Contact: John C Lantis, MD 212-523-4797 jlantis@chpnet.org

Locations
United States, New York
St. Luke's-Roosevelt Hospital Center Recruiting
New York, New York, United States, 10025
Contact: Cynthia A Gendics, RN    212-523-2979    cgendics@chpnet.org   
Contact: John C Lantis, MD    212-523-4797    jlantis@chpnet.org   
Principal Investigator: John C Lantis, MD         
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Kinetic Concepts, Inc.
Investigators
Principal Investigator: John C Lantis, MD St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT02009501     History of Changes
Other Study ID Numbers: VAC/09/05/ULTA
Study First Received: November 24, 2013
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Infected wounds
NPWTi
VAC Instill
Biofilm

Additional relevant MeSH terms:
Varicose Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Wound Infection
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Phlebitis
Peripheral Vascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014