VAC Bioburden Wound Care Assessment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the microbiologic burden and need for further operative debridement of patients undergoing primary surgical debridement of infected tissue, soft tissue abscesses, or traumatic wounds of the upper and lower extremity.

Detailed Description
-----------------
Bacterial bio-burden as measured by quantitative microbial PCR prior to debridement, immediately following initial debridement, after 2 days of VAC veraflo (or conventional VAC) therapy, and at the time of repeat operative debridements, if needed. We will use the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX.) to report on the bacterial burden (reported on a log scale of bacteria per gram) present at the time of debridement. Our goal is to be able to assess the bioburden quantitatively at each time point to discern a change. Exploratory outcomes to be measured: number of operative debridements required prior to reconstruction, number of days until final reconstruction, number of days until decision is made by surgeon that further debridements are no longer necessary, length of hospital stay, wound surface area will be monitored from enrollment through when the veraflo is removed. This is likely a 3-month interval.

Official Title
-----------------
Does Negative Pressure Wound Therapy With Instillation Reduce the Bioburden of Infections of the Upper and Lower Extremity?

Conditions
-----------------
Upper Extremity Wound, Lower Extremity Wound, Soft Tissue Abscesses, Traumatic Wounds

Intervention / Treatment
-----------------
* Device: Wound Vac is applied


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+yo with an injury or infection of the upper or lower extremity for which surgical debridement (in the operating room) followed by VAC application is planned. Exclusion Criteria: - Patient with wounds distal to the ankle.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Screen 60 subjects in hopes to enroll 40. There will be 20 subjects per arm. All subjects will have a wound vac applied. The randomization will be whether or not irrigation is included.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wound vac application<br>Wound vac application for open upper/lower extremity open wound | Device: Wound Vac is applied<br>* A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.<br>|
| Active Comparator: Wound vac application including irrigation<br>Wound vac application WITH irrigation for upper/lower extremity open wound | Device: Wound Vac is applied<br>* A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement | Bacterial bio-burden as measured by microbial PCR prior to debridement using the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX). Reported as the number of participants with low (< 1x10^5), medium (1x10^5 to 1x10^7), and high (> 1x10^7) counts of bacteria per gram. | Day 1 (day of first operative debridement) | 
| Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement | Bacterial bio-burden as measured by microbial PCR after debridement using the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX). Reported as the number of participants with low (< 1x10^5), medium (1x10^5 to 1x10^7), and high (> 1x10^7) counts of bacteria per gram. | Day 1 (day of first operative debridement) | 
| Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement | Bacterial bio-burden as measured by microbial PCR prior to debridement using the MicroGen PCR platform (DBA Microgen Diagnostics, LLC, Lubbock, TX). Reported as the number of participants with low (< 1x10^5), medium (1x10^5 to 1x10^7), and high (> 1x10^7) counts of bacteria per gram. | Day 2 (day of second operative debridement) |