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

NCT ID: NCT02009501

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-06-30

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.

Conditions

Lower Extremity Wound Infected; Venous Stasis Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

VAC VeraFlo with Dakins Instillation

Intervention Type: DEVICE

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 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.

Group Type: ACTIVE_COMPARATOR

VAC Ulta Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

NPWTi; VAC Instill; VAC; NPWT

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kinetic Concepts, Inc.

INDUSTRY

Sponsor Role: collaborator

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John C Lantis, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's-Roosevelt Hospital Center

Locations

St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Countries

United States

Other Identifiers

VAC/09/05/ULTA

Identifier Type: -

Identifier Source: org_study_id