VeraFlo With Prontosan® and Wound and Fracture Healing.

• Sponsor: Brett Crist (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02621073
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

To answer the question: "Do Prontosan instillations decrease time to wound and fracture healing and decrease bacterial load compared to wound vac treatment without Prontosan?," we will enroll up to 30 subjects (for an anticipated 20 complete data sets) into this trial. The subjects will be split equally into two different groups by randomization. One groups will have wound vac therapy with Prontosan, and one group will have wound vac therapy without Prontosan. Data related to wound and fracture healing and bacterial load will be assessed between the two groups to determine if wound vac therapy with Prontosan speeds up healing time and decreases bacterial load.

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: VeraFlo with Prontosan; Device: V.A.C Ulta System	N/A

Detailed Description

Surgical site infections (SSIs) are a devastating and relatively common surgical complication, occurring in 2% to 5% of patients undergoing surgery in the United States. SSIs can significantly increase patient morbidity, hospital stay duration, healthcare costs, and patient mortality (Anderson 2011).

Negative Pressure Wound Therapy (NPWT) with Vacuum-Assisted Closure (VAC) is an established adjunctive treatment option for open wounds that offers the ability to promote healing. However, there is limited evidence for its utility with active infections. Wounds that are acutely infected or that contain an adherent biofilm present a challenging problem (Kim et al 2015).

Wound VAC therapy involves cleaning the wound, applying a custom-fit foam to cover the wound, placing a transparent drape over the wound and adjacent skin, and attaching tubing to connect the foam to a VAC suction canister. NPWT is achieved with a pulling force supplied by the VAC suction canister. Typically, suction will remain at a constant pressure until the dressing is removed. Continuous VAC therapy was recently reported to be more effective than standard moist wound care in surgical site infection after ankle surgery (Zhou et al. 2015).

VAC therapy with instillations is a novel treatment option that provides the combination of negative pressure with intermittent instillation of a solution. Polihexanide (Prontosan®) is a modern antiseptic that combines a broad antimicrobial spectrum with low toxicity, high tissue compatibility, no reported adsorption and good applicability as solution, gel, ointment, foam and in wound dressing. 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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Does VeraFlo With Prontosan® Decrease Time to Wound and Fracture Healing in Patients With Infected Lower Extremity Fractures With Indwelling Hardware?
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: VeraFlo with Prontosan 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).	Drug: VeraFlo with Prontosan; VeraFlo device with Prontosan instillation (n=10).
Active Comparator: V.A.C Ulta System The V.A.C.Ulta™ Therapy System is an integrated wound therapy system that provides NPWT (negative pressure wound therapy), without instillation.	Device: V.A.C Ulta System; V.A.C. Ulta Negative Pressure Wound Therapy System without instillation (n=10).

Outcome Measures

Primary Outcome Measures

1. Bacterial Load [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.

Secondary Outcome Measures

1. Number of Operative Debridements Until Wound Healed [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients 18 years and older

• Patients who will be undergoing surgical management (including the use of NPWT therapy) of an infected lower extremity status-post open reduction and internal fixation (ORIF)

Exclusion Criteria:

• Pregnant females

• Incarcerated patients and those not able to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri	Columbia	Missouri	United States	65212

Sponsors and Collaborators

• Brett Crist

Investigators

• Principal Investigator: Brett D Crist, MD, University of Missouri, Missouri Orthopaedic Institute

Study Documents (Full-Text)

• Study Protocol - Dec 31, 2015

More Information

Publications

None provided.

• Responsible Party: Brett Crist, Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT02621073
• Other Study ID Numbers: 2003641
• First Posted: Dec 3, 2015
• Last Update Posted: Jun 20, 2019
• Last Verified: May 1, 2019

• Keywords provided by Brett Crist, Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia: lower extremity; status-post ORIF

Study Results

Participant Flow

Arm/Group Title	VeraFlo With Prontosan	V.A.C Ulta System
Arm/Group Description	VeraFlo with Prontosan: VeraFlo device with Prontosan instillation.	V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation
Period Title: Overall Study
STARTED	4	3
COMPLETED	1	0
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	VeraFlo With Prontosan	V.A.C Ulta System	Total
Arm/Group Description	VeraFlo with Prontosan: VeraFlo device with Prontosan instillation	V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation	Total of all reporting groups
Overall Participants	4	3	7
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	51.25	59.3	54.7
Sex: Female, Male (Count of Participants)
Female	1 25%	2 66.7%	3 42.9%
Male	3 75%	1 33.3%	4 57.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
BMI (kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [kg/m^2]	35.8	28.3	32.6

Outcome Measures

1. Primary Outcome

Title	Bacterial Load
Description	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.
Time Frame	approximately 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VeraFlo With Prontosan	V.A.C Ulta System
Arm/Group Description	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).	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).
Measure Participants	4	3
No Bacterial Growth	1 25%	0 0%
Scant Bacterial Growth	1 25%	1 33.3%
Moderate Bacterial Growth	1 25%	1 33.3%
Heavy Bacterial Growth	1 25%	1 33.3%

2. Secondary Outcome

Title	Number of Operative Debridements Until Wound Healed
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VeraFlo With Prontosan	V.A.C Ulta System
Arm/Group Description	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).	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).
Measure Participants	4	3
Mean (Full Range) [Operations]	2.3	2.3

Adverse Events

Time Frame	1 year
Arm/Group Title	VeraFlo With Prontosan		V.A.C Ulta System
Arm/Group Description	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).		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).
All Cause Mortality
	VeraFlo With Prontosan		V.A.C Ulta System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/3 (0%)
Serious Adverse Events
	VeraFlo With Prontosan		V.A.C Ulta System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/4 (75%)		1/3 (33.3%)
Infections and infestations
Deep Surgical Site Infection	3/4 (75%)	3	0/3 (0%)	0
Musculoskeletal and connective tissue disorders
Below Knee Amputation	0/4 (0%)	0	1/3 (33.3%)	1
Syndesmosis Rupture	1/4 (25%)	1	0/3 (0%)	0
Other (Not Including Serious) Adverse Events
	VeraFlo With Prontosan		V.A.C Ulta System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.