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

NCT01867580 | Completed Results DMC

• 1 other identifier: AHS.2011.ULTA.04
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 7

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.

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• Number of Inpatient Operating Room Debridements

  Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room

  until the wound is deemed ready for closure or coverage by the investigator up to 64 days

Secondary Outcomes (1)

• The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.

  Immediately following initial post debridement to the first dressing change up to 72 hours

Study Arms (2)

V.A.C.Ulta with Prontosan instillation

EXPERIMENTAL

Treatment Arm

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

V.A.C.Ulta without instillation

ACTIVE COMPARATOR

Control Arm

Device: V.A.C.Ulta without instillation

Interventions

V.A.C.Ulta with Prontosan instillation DEVICE

NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)

V.A.C.Ulta with Prontosan instillation

V.A.C.Ulta without instillation DEVICE

NPWT only

V.A.C.Ulta without instillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KCI USA, Inc: lead

Study Sites (7)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

St. Luke's University Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

Prontosan was used for instillation in this study. Approximately \~75% of wounds were not infected. Therefore benefits from a solution with antiseptic properties would be expected to be limited. Acelity is planning to conduct a study using saline.

Results Point of Contact

• Title: Anthony Tate, RN, BSN
• Organization: KCI, an Acelity Company

anthony.tate@kci1.com

210-515-4060

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 2, 2024
• Results First Posted: November 29, 2017

Record last verified: 2024-11

Locations

US (7)