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

NCT02266771 | Completed

• 1 other identifier: 2169
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Keywords

Negative Pressure Wound Therapy, Wound VAC, Instillation

Outcome Measures

Primary Outcomes (1)

• Number of days between the initial and final surgical procedure.

  6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

NPWT with Instillation

ACTIVE COMPARATOR

Negative Pressure Wound Therapy with Instillation.

Device: NPWT with Instillation

NPWT without Instillation

PLACEBO COMPARATOR

Negative Pressure Wound Therapy without Instillation

Device: NPWT

Interventions

NPWT with Instillation DEVICE

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

NPWT with Instillation

NPWT DEVICE

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

NPWT without Instillation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• LifeBridge Health: lead
• Kinetic Concepts, Inc.: collaborator

Study Sites (1)

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

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Janet D Conway, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 17, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)