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

KCI USA, Inc

Status: Completed

Conditions: Wounds and Injuries

Treatments: Device: V.A.C.Ulta without instillation; Device: V.A.C.Ulta with Prontosan instillation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01867580

AHS.2011.ULTA.04

Details and patient eligibility

About

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

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 2 patient groups

V.A.C.Ulta with Prontosan instillation

Experimental group

Description:

Treatment Arm

Treatment:

Device: V.A.C.Ulta with Prontosan instillation

V.A.C.Ulta without instillation

Active Comparator group

Description:

Control Arm

Treatment:

Device: V.A.C.Ulta without instillation