Overview

This trial has been completed.

Condition wounds and injuries
Treatments v.a.c.ulta with instillation, v.a.c.ulta without instillation
Sponsor KCI USA, Inc.
Start date May 2013
End date August 2015
Trial size 183 participants
Trial identifier NCT01867580, AHS.2011.ULTA.04

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment Arm
v.a.c.ulta with instillation
NPWT with instillation of a wound cleanser
(Active Comparator)
Control Arm
v.a.c.ulta without instillation
NPWT only

Primary Outcomes

Measure
Number of Operative Debridements
time frame: until the wound is deemed ready for closure or coverage by the investigator up to 64 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by KCI USA, Inc..