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

Venous Stasis Ulcers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009501
• Other study ID #: VAC/09/05/ULTA
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2018
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Extremity Wound Infected
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Varicose Ulcer
• Venous Stasis Ulcers
• Wound Infection
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	Kinetic Concepts, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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