Impact of V.A.C. Veraflo Therapy in Wounds Requiring Debridement Within an Orthopedic Practice

The objective to this study is to determine the effectiveness of V.A.C.Veraflo negative pressure wound therapy with instillation, when compared to historical controls of V.A.C Therapy without instillation in the management of wounds.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: NPWT with Instillation; Device: NPWT

Detailed Description

The V.A.C.Ulta™ Negative Pressure Wound Therapy System is a 510(k) -cleared, Class II device (K100657) with the following indication for use: "the V.A.C.Ulta™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. Negative Pressure Wound Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudates and infectious material. The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The V.A.C.Ulta™ Negative Pressure Wound Therapy System, with and without instillation, is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts". The V.A.C. Ulta™ Therapy Unit is for use with only V.A.C.® Dressings (V.A.C.® GranuFoam™, V.A.C. GranuFoam Silver®, V.A.C. WhiteFoam,® V.A.C. VeraFlo™ Dressing Systems) and disposables. The V.A.C. VeraFlo™ Dressing System is intended for use with V.A.C. VeraFlo™ Therapy as provided by the V.A.C.Ulta™ Therapy Unit. The V.A.C. VeraFlo™ Dressing was cleared under the V.A.C Ulta™ Negative Pressure Wound Therapy System 510(k) (K100657). It is recommended for use with open wounds, including wounds with shallow undermining or tunnel areas where the distal aspect is visible.

Prontosan® Wound Irrigation Solution is a clear, odorless, colorless solution consisting of polyhexamethylene biguanide (PHMB), betaine, sodium hydroxide and purified water. PHMB, also known as Polyhexanide, is a polymer biguanide. PHMB is a cationic preservative which inhibits the growth of microorganisms within the product. Betaine is a zwitterionic (both, negatively and positively charged) surfactant. Prontosan® is a FDA 510(k) cleared device intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post surgical wounds, and abrasions.

The objective to this study is to determine the effectiveness of V.A.C.Veraflo negative pressure wound therapy with Prontosan instillation, when compared to historical controls of V.A.C Therapy without instillation in the management of wounds. We will measure any difference in length of hospital stay, number of days until final surgical procedure, and the number of trips to the or for additional debridement. Patients will be considered infection free when clinical signs of infection are absent and lab values become normal.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed Informed Consent.
• Patients requiring surgical debridement for wounds with exposed hardware and/or bone, traumatic wounds, dehisced wounds, post-surgical wounds, and pressure ulcers/sores requiring debridement.
• Age: 18 years and above.
• Gender: Male or Female.
• No use of Investigational Agents/Devices on study or within 30 days prior to enrollment.
• Subjects who will be locally available for the next 6 months.

Exclusion Criteria:

• Wounds involving prosthetic joints.
• Patients who are unable to adhere to scheduled study visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NPWT with Instillation; Negative Pressure Wound Therapy with Instillation.	Device: NPWT with Instillation; Kinetic Concepts Inc. V.A.C Ulta Negative Pressure Wound Therapy System with V.A.C. VeraFlo Instillation
Placebo Comparator: NPWT without Instillation; Negative Pressure Wound Therapy without Instillation	Device: NPWT; Kinetic Concepts Inc. V.A.C Ulta Negative Pressure Wound Therapy System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of days between the initial and final surgical procedure.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	6 months
Number of days until wound closure	6 months
Number of operative debridements	6 months
Recurrence of wound post discharge	30 days
Wound related re-admission	30 days

Collaborators and Investigators

• Sponsor: LifeBridge Health
• Collaborators: Kinetic Concepts, Inc.
• Investigators: Principal Investigator: Janet D Conway, MD, Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: September 24, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Negative Pressure Wound Therapy, Wound VAC, Instillation
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No