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

Not Applicable

Completed

• Conditions: Venous Stasis Ulcers; Lower Extremity Wound Infected
• Interventions: Device: VAC VeraFlo with Dakins Instillation; Device: VAC Ulta Therapy

• Registration Number: NCT02009501
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-24
• Study First Submitted QC: 2013-12-08
• Study First Posted: 2013-12-12
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Results First Submitted: 2018-02-22
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-23
• Last Update Submitted: 2018-11-23
• Results First Posted: 2018-11-27
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VAC VeraFlo with Dakins Instillation	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.
VAC Ulta Therapy	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

St. Luke's-Roosevelt Hospital Center; 🇺🇸 New York, New York, United States