A Prospective, 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 ID
AHS.2011.ULTA.04

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Contact


Principal Investigator

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

Brief Overview


The purpose of this study is to examine the effectiveness of the V.A.C.Ulta Negative
Pressure Wound Therapy System and V.A.C. VeraFlo Dressing System in wounds that require
operative debridement.

Participant Eligibility


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