VeraFlo With Prontosan® and Wound and Fracture Healing.

NCT02621073 | Terminated Results

• 1 other identifier: 2003641
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To answer the question: "Do Prontosan instillations decrease time to wound and fracture healing and decrease bacterial load compared to wound vac treatment without Prontosan?," we will enroll up to 30 subjects (for an anticipated 20 complete data sets) into this trial. The subjects will be split equally into two different groups by randomization. One groups will have wound vac therapy with Prontosan, and one group will have wound vac therapy without Prontosan. Data related to wound and fracture healing and bacterial load will be assessed between the two groups to determine if wound vac therapy with Prontosan speeds up healing time and decreases bacterial load.

Conditions

Infection

Keywords

lower extremity; status-post ORIF

Outcome Measures

Primary Outcomes (1)

• Bacterial Load

  Semiquantitative wound culture(s) done at each debridement procedure, (up to 3). Organism quantities are listed as scant, moderate, or heavy. Report includes identification of organism, and susceptibility. Wound cultures will be analyzed and reported by the University of Missouri Hospital Laboratory.

  approximately 4 weeks

Secondary Outcomes (1)

• Number of Operative Debridements Until Wound Healed

  12 months

Study Arms (2)

VeraFlo with Prontosan

ACTIVE COMPARATOR

V.A.C. VeraFlo™ Therapy, the only NPWT system with an instillation feature which allows solution to dwell in the wound for thorough contact with the wound bed. The solution being instilled is Prontosan: Unlike other antiseptics, the antimicrobial efficacy of Prontosan® is not impaired in human wound fluid, human tissue or by high loads of blood or albumin. Furthermore, Prontosan® blocks the microbial attachment to surfaces and has been shown to effectively remove biofilms in vitro and in vivo (Hubner et al 2010).

Drug: VeraFlo with Prontosan

V.A.C Ulta System

ACTIVE COMPARATOR

The V.A.C.Ulta™ Therapy System is an integrated wound therapy system that provides NPWT (negative pressure wound therapy), without instillation.

Device: V.A.C Ulta System

Interventions

VeraFlo with Prontosan DRUG

VeraFlo device with Prontosan instillation (n=10).

VeraFlo with Prontosan

V.A.C Ulta System DEVICE

V.A.C. Ulta Negative Pressure Wound Therapy System without instillation (n=10).

V.A.C Ulta System

Eligibility Criteria

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

You may qualify if:

• Patients 18 years and older
• Patients who will be undergoing surgical management (including the use of NPWT therapy) of an infected lower extremity status-post open reduction and internal fixation (ORIF)

You may not qualify if:

• Pregnant females
• Incarcerated patients and those not able to give informed consent

Sponsors & Collaborators

• Brett Crist: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Infections

Results Point of Contact

• Title: Brett Crist, MD
• Organization: University of Missouri, Department of Orthopaedics

cristb@health.missouri.edu

573-882-6562

Study Officials

• Brett D Crist, MD

  University of Missouri, Missouri Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 20, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-05

Locations

US (1)