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.

Study Overview

• Status: Completed
• Conditions: Venous Stasis Ulcers; Lower Extremity Wound Infected
• Intervention / Treatment: Device: VAC VeraFlo with Dakins Instillation; Device: VAC Ulta Therapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10025
      • St. Luke's-Roosevelt Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: NPWT; VAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers	Biopsies for bacteria colony-forming units obtained at pre surgical debridement (baseline) and day 7.	Baseline and day 7

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborators: Kinetic Concepts, Inc.
• Investigators: Principal Investigator: John C Lantis, MD, St. Luke's-Roosevelt Hospital Center

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: November 24, 2013
• First Submitted That Met QC Criteria: December 8, 2013
• First Posted (ESTIMATE): December 12, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 23, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Biofilm; Infected wounds; NPWTi; VAC Instill
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Infections; Leg Ulcer; Skin Ulcer; Varicose Veins; Wounds and Injuries; Wound Infection; Varicose Ulcer
• Other Study ID Numbers: VAC/09/05/ULTA