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

St. Luke's-Roosevelt Hospital Center

Status: Completed

Conditions: Venous Stasis Ulcers; Lower Extremity Wound Infected

Treatments: Device: VAC Ulta Therapy; Device: VAC VeraFlo with Dakins Instillation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02009501

VAC/09/05/ULTA

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

VAC VeraFlo with Dakins Instillation

Active Comparator group

Description:

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.

Treatment:

Device: VAC VeraFlo with Dakins Instillation

VAC Ulta Therapy

Active Comparator group

Description:

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.

Treatment:

Device: VAC Ulta Therapy