Trial Outcomes & Findings for VeraFlo With Prontosan® and Wound and Fracture Healing. (NCT NCT02621073)

NCT ID: NCT02621073

Last Updated: 2019-06-20

Results Overview

Semiquantitative wound culture(s) done at each debridement procedure, (up to 3). Organism quantities are listed as scant, moderate, or heavy. Report includes identification of organism, and susceptibility. Wound cultures will be analyzed and reported by the University of Missouri Hospital Laboratory.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: approximately 4 weeks
• Results posted on: 2019-06-20

Participant Flow

Participant milestones

Measure	VeraFlo With Prontosan VeraFlo with Prontosan: VeraFlo device with Prontosan instillation.	V.A.C Ulta System V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation
Overall Study STARTED	4	3
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	VeraFlo With Prontosan VeraFlo with Prontosan: VeraFlo device with Prontosan instillation.	V.A.C Ulta System V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	3	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	VeraFlo With Prontosan n=4 Participants VeraFlo with Prontosan: VeraFlo device with Prontosan instillation	V.A.C Ulta System n=3 Participants V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation	Total n=7 Participants Total of all reporting groups
Age, Continuous	51.25 years n=4 Participants	59.3 years n=3 Participants	54.7 years n=7 Participants
Sex: Female, Male Female	1 Participants n=4 Participants	2 Participants n=3 Participants	3 Participants n=7 Participants
Sex: Female, Male Male	3 Participants n=4 Participants	1 Participants n=3 Participants	4 Participants n=7 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	35.8 kg/m^2 n=4 Participants	28.3 kg/m^2 n=3 Participants	32.6 kg/m^2 n=7 Participants

PRIMARY outcome

Timeframe: approximately 4 weeks

Semiquantitative wound culture(s) done at each debridement procedure, (up to 3). Organism quantities are listed as scant, moderate, or heavy. Report includes identification of organism, and susceptibility. Wound cultures will be analyzed and reported by the University of Missouri Hospital Laboratory.

Outcome measures

Measure	VeraFlo With Prontosan n=4 Participants V.A.C. VeraFlo™ Therapy, the only NPWT system with an instillation feature which allows solution to dwell in the wound for thorough contact with the wound bed. The solution being instilled is Prontosan: Unlike other antiseptics, the antimicrobial efficacy of Prontosan® is not impaired in human wound fluid, human tissue or by high loads of blood or albumin. Furthermore, Prontosan® blocks the microbial attachment to surfaces and has been shown to effectively remove biofilms in vitro and in vivo (Hubner et al 2010). VeraFlo with Prontosan: VeraFlo device with Prontosan instillation (n=10).	V.A.C Ulta System n=3 Participants The V.A.C.Ulta™ Therapy System is an integrated wound therapy system that provides NPWT (negative pressure wound therapy), without instillation. V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation (n=10).
Bacterial Load No Bacterial Growth	1 Participants	0 Participants
Bacterial Load Scant Bacterial Growth	1 Participants	1 Participants
Bacterial Load Moderate Bacterial Growth	1 Participants	1 Participants
Bacterial Load Heavy Bacterial Growth	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	VeraFlo With Prontosan n=4 Participants V.A.C. VeraFlo™ Therapy, the only NPWT system with an instillation feature which allows solution to dwell in the wound for thorough contact with the wound bed. The solution being instilled is Prontosan: Unlike other antiseptics, the antimicrobial efficacy of Prontosan® is not impaired in human wound fluid, human tissue or by high loads of blood or albumin. Furthermore, Prontosan® blocks the microbial attachment to surfaces and has been shown to effectively remove biofilms in vitro and in vivo (Hubner et al 2010). VeraFlo with Prontosan: VeraFlo device with Prontosan instillation (n=10).	V.A.C Ulta System n=3 Participants The V.A.C.Ulta™ Therapy System is an integrated wound therapy system that provides NPWT (negative pressure wound therapy), without instillation. V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation (n=10).
Number of Operative Debridements Until Wound Healed	2.3 Operations Interval 2.0 to 3.0	2.3 Operations Interval 2.0 to 3.0

Adverse Events

VeraFlo With Prontosan

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

V.A.C Ulta System

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	VeraFlo With Prontosan n=4 participants at risk V.A.C. VeraFlo™ Therapy, the only NPWT system with an instillation feature which allows solution to dwell in the wound for thorough contact with the wound bed. The solution being instilled is Prontosan: Unlike other antiseptics, the antimicrobial efficacy of Prontosan® is not impaired in human wound fluid, human tissue or by high loads of blood or albumin. Furthermore, Prontosan® blocks the microbial attachment to surfaces and has been shown to effectively remove biofilms in vitro and in vivo (Hubner et al 2010). VeraFlo with Prontosan: VeraFlo device with Prontosan instillation (n=10).	V.A.C Ulta System n=3 participants at risk The V.A.C.Ulta™ Therapy System is an integrated wound therapy system that provides NPWT (negative pressure wound therapy), without instillation. V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation (n=10).
Musculoskeletal and connective tissue disorders Below Knee Amputation	0.00% 0/4 • 1 year	33.3% 1/3 • Number of events 1 • 1 year
Infections and infestations Deep Surgical Site Infection	75.0% 3/4 • Number of events 3 • 1 year	0.00% 0/3 • 1 year
Musculoskeletal and connective tissue disorders Syndesmosis Rupture	25.0% 1/4 • Number of events 1 • 1 year	0.00% 0/3 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Brett Crist, MD

University of Missouri, Department of Orthopaedics

Phone: 573-882-6562

Email: cristb@health.missouri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place