A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement
NCT ID: NCT01867580
Last Updated: 2024-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
181 participants
INTERVENTIONAL
2013-05-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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V.A.C.Ulta with Prontosan instillation
Treatment Arm
V.A.C.Ulta with Prontosan instillation
NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)
V.A.C.Ulta without instillation
Control Arm
V.A.C.Ulta without instillation
NPWT only
Interventions
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V.A.C.Ulta with Prontosan instillation
NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)
V.A.C.Ulta without instillation
NPWT only
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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KCI USA, Inc
INDUSTRY
Responsible Party
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Locations
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Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
St. Luke's University Hospital
Bethlehem, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
Countries
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Other Identifiers
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AHS.2011.ULTA.04
Identifier Type: -
Identifier Source: org_study_id