VeraFlo With Prontosan® and Wound and Fracture Healing.
| Status: | Terminated |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/5/2018 |
| Start Date: | November 2015 |
| End Date: | December 2017 |
Does VeraFlo With Prontosan® Decrease Time to Wound and Fracture Healing in Patients With Infected Lower Extremity Fractures With Indwelling Hardware?
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.
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.
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).
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).
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
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University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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