Infection
Conditions
Keywords
lower extremity, status-post ORIF
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.
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).
Interventions
DRUGVeraFlo with Prontosan
VeraFlo device with Prontosan instillation (n=10).
DEVICEV.A.C Ulta System
V.A.C. Ulta Negative Pressure Wound Therapy System without instillation (n=10).
Sponsors
Brett Crist
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Operative Debridements Until Wound Healed | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VeraFlo With Prontosan VeraFlo with Prontosan: VeraFlo device with Prontosan instillation | 4 |
| V.A.C Ulta System V.A.C Ulta System: V.A.C. Ulta Negative Pressure Wound Therapy System without instillation | 3 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 3 | 2 |
Baseline characteristics
| Characteristic | VeraFlo With Prontosan | V.A.C Ulta System | Total |
|---|---|---|---|
| Age, Continuous | 51.25 years | 59.3 years | 54.7 years |
| BMI | 35.8 kg/m^2 | 28.3 kg/m^2 | 32.6 kg/m^2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 3 / 4 | 1 / 3 |
Outcome results
Primary
Bacterial Load
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VeraFlo With Prontosan | Bacterial Load | No Bacterial Growth | 1 Participants |
| VeraFlo With Prontosan | Bacterial Load | Scant Bacterial Growth | 1 Participants |
| VeraFlo With Prontosan | Bacterial Load | Moderate Bacterial Growth | 1 Participants |
| VeraFlo With Prontosan | Bacterial Load | Heavy Bacterial Growth | 1 Participants |
| V.A.C Ulta System | Bacterial Load | Heavy Bacterial Growth | 1 Participants |
| V.A.C Ulta System | Bacterial Load | No Bacterial Growth | 0 Participants |
| V.A.C Ulta System | Bacterial Load | Moderate Bacterial Growth | 1 Participants |
| V.A.C Ulta System | Bacterial Load | Scant Bacterial Growth | 1 Participants |
Secondary
Number of Operative Debridements Until Wound Healed
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| VeraFlo With Prontosan | Number of Operative Debridements Until Wound Healed | 2.3 Operations |
| V.A.C Ulta System | Number of Operative Debridements Until Wound Healed | 2.3 Operations |