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

NCT ID: NCT02266771

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-12-31

Brief Summary

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.

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.

Conditions

Wounds and Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPWT with Instillation

Negative Pressure Wound Therapy with Instillation.

Group Type: ACTIVE_COMPARATOR

NPWT with Instillation

Intervention Type: DEVICE

Kinetic Concepts Inc. V.A.C Ulta Negative Pressure Wound Therapy System with V.A.C. VeraFlo Instillation

NPWT without Instillation

Negative Pressure Wound Therapy without Instillation

Group Type: PLACEBO_COMPARATOR

NPWT

Intervention Type: DEVICE

Kinetic Concepts Inc. V.A.C Ulta Negative Pressure Wound Therapy System

Interventions

NPWT with Instillation

Kinetic Concepts Inc. V.A.C Ulta Negative Pressure Wound Therapy System with V.A.C. VeraFlo Instillation

Intervention Type: DEVICE

NPWT

Kinetic Concepts Inc. V.A.C Ulta Negative Pressure Wound Therapy System

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Sponsors

Kinetic Concepts, Inc.

INDUSTRY

Sponsor Role: collaborator

LifeBridge Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janet D Conway, MD

Role: PRINCIPAL_INVESTIGATOR

Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health

Locations

Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

2169

Identifier Type: -

Identifier Source: org_study_id