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

NCT02009501 | Completed Results

• 1 other identifier: VAC/09/05/ULTA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Infected wounds; NPWTi; VAC Instill; Biofilm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

VAC VeraFlo with Dakins Instillation

ACTIVE COMPARATOR

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 Ulta Therapy

ACTIVE COMPARATOR

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

Interventions

VAC VeraFlo with Dakins Instillation 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.

Also known as: NPWTi, VAC Instill

VAC VeraFlo with Dakins Instillation

VAC Ulta Therapy 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.

Also known as: VAC, NPWT

VAC Ulta Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients undergoing chemotherapy
• Patients being treated with immunosuppressive drugs or corticosteroids
• Patients with an autoimmune disease
• Patients who have participated in an experimental drug or device study within the last 15 days
• Patients that have been entered in this evaluation previously as an evaluable patient.

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead
• Kinetic Concepts, Inc.: collaborator

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Wound Infection

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Infections

Limitations and Caveats

Limitation: small sample size and associated large data variance. Absence of a standardized biopsy schema given the heterogeneous distribution of biofilm-protected bacteria within wounds, may not properly capture effects of the treatment modalities.

Results Point of Contact

• Title: Dr. John C. Lantis II
• Organization: Mount Sinai St. Luke's

JLantis@chpnet.org

Study Officials

• John C Lantis, MD

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: December 12, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 27, 2018
• Results First Posted: November 27, 2018

Record last verified: 2018-11

Locations

US (1)