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A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867580
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : November 29, 2017
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.

Brief Summary:
The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Device: V.A.C.Ulta with Prontosan instillation Device: V.A.C.Ulta without instillation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multi-Center Trial Evaluating the Effectiveness of the V.A.C. Ulta Negative Pressure Wound Therapy System With V.A.C. VeraFlo Dressing System in Operatively Debrided Wounds
Study Start Date : May 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: V.A.C.Ulta with Prontosan instillation
Treatment Arm
Device: V.A.C.Ulta with Prontosan instillation
NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)

Active Comparator: V.A.C.Ulta without instillation
Control Arm
Device: V.A.C.Ulta without instillation
NPWT only




Primary Outcome Measures :
  1. Number of Inpatient Operating Room Debridements [ Time Frame: until the wound is deemed ready for closure or coverage by the investigator up to 64 days ]
    Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room


Secondary Outcome Measures :
  1. The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis. [ Time Frame: Immediately following initial post debridement to the first dressing change up to 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The Subject:

  • has a wound prior to informed consent
  • will be admitted as an inpatient
  • is >= 18 years of age at time of consent
  • is able to provide his/her own informed consent
  • is willing and able to return for all scheduled and required study visits
  • has an open wound >= 4cm in any plane of measurement excluding tunnels after initial surgical debridement
  • has a wound that is appropriate for NPWT according to approved indications for use
  • has not participated in a clinical trial within the past 30 days
  • has a 30 day wound history available if the wound has been previously treated

Exclusion Criteria:

The Subject:

  • is pregnant as determined by a positive serum or urine pregnancy test at the time of screening
  • has a life expectancy of < 12 months
  • is not healthy enough to undergo surgery for any reason
  • has, in the investigator's opinion, any clinically significant condition that would impair the participant's ability to comply with the study procedures
  • has, in the opinion of the investigator, a condition that will not allow the subject to tolerate the therapy (e.g. painful conditions such as vasculitis)
  • has rheumatoid arthritis
  • has a bleeding disorder or coagulopathy
  • has a wound that contains antibiotic cement or beads
  • has an ischemic lower extremity wound as determined by lack of detectable pulses in the extremity or ankle-brachial pressure indices of < 0.9 with a history of diabetes, or < 0.6 if the subject is non-diabetic
  • has a known allergy or hypersensitivity to V.A.C. Therapy dressing components including polyurethane or polyvinyl alcohol (drape and foam), or materials that contain acrylic adhesive (drape adhesive)
  • has a known allergy or hyper sensitivity to 3M Cavilon No Sting Barrier Film or any of its components including Hexamethyldisiloxane, isooctane, acrylate terpolymer, polyphenylmethysiloxane, copolymer
  • has a know allergy or hypersensitivity to Prontosan or any of its components including polyhexamethylene biguanide (PHMB), or undecylenamidopropyl betaine
  • has received NPWT on the study wound within the last 30 days
  • has a wound that is contraindicated with Prontosan

    a. presence of hyaline cartilage in the wound

  • has a wound that is contraindicated with V.A.C. Therapy including:

    1. malignancy in the wound
    2. untreated osteomyelitis
    3. non-enteric or unexplored fistulas
    4. necrotic tissue with eschar remaining in the wound after debridement (NOTE: Once necrotic tissue or eschar is removed from the wound bed, subjects may be included)
    5. unprotected, exposed blood vessels, anastomotic sites, organs, or nerves in direct contact with foam
  • use of intervening layers between the wound bed and foam
  • has a wound that is contraindicated with V.A.C. VeraFlo Therapy including:

    1. Thoracic or abdominal cavities
    2. Unexplored wounds that may communicate with adjacent body cavities
  • has a wound that is closed after the initial debridement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867580


Locations
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United States, District of Columbia
Medstar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
St. Luke's University Hospital
Bethlehem, Pennsylvania, United States, 18015
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
KCI USA, Inc.
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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT01867580    
Other Study ID Numbers: AHS.2011.ULTA.04
First Posted: June 4, 2013    Key Record Dates
Results First Posted: November 29, 2017
Last Update Posted: March 9, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Wounds and Injuries