Lower Extremity Wound, Soft Tissue Abscesses, Traumatic Wounds, Upper Extremity Wound
Conditions
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.
Interventions
DEVICEWound Vac is applied
A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
Sponsors
3M
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement | Day 1 (day of first operative 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. |
| Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement | Day 1 (day of first operative 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. |
| Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement | Day 2 (day of second operative 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wound Vac Application Wound vac application for open upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied. | 3 |
| Wound Vac Application Including Irrigation Wound vac application WITH irrigation for upper/lower extremity open wound
Wound Vac is applied: A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied. | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Wound Vac Application | Wound Vac Application Including Irrigation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
Primary
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.
Time frame: Day 1 (day of first operative debridement)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Wound Vac Application | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement | Low | 1 Participants |
| Wound Vac Application | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement | Medium | 1 Participants |
| Wound Vac Application | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement | High | 1 Participants |
| Wound Vac Application Including Irrigation | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement | Low | 1 Participants |
| Wound Vac Application Including Irrigation | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement | Medium | 1 Participants |
| Wound Vac Application Including Irrigation | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) After First Debridement | High | 0 Participants |
Primary
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.
Time frame: Day 1 (day of first operative debridement)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Wound Vac Application | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement | Low | 0 Participants |
| Wound Vac Application | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement | Medium | 1 Participants |
| Wound Vac Application | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement | High | 2 Participants |
| Wound Vac Application Including Irrigation | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement | High | 1 Participants |
| Wound Vac Application Including Irrigation | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement | Low | 0 Participants |
| Wound Vac Application Including Irrigation | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to First Debridement | Medium | 1 Participants |
Primary
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.
Time frame: Day 2 (day of second operative debridement)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Wound Vac Application | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement | Low | 1 Participants |
| Wound Vac Application | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement | Medium | 1 Participants |
| Wound Vac Application | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement | High | 0 Participants |
| Wound Vac Application | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement | Not Detected | 1 Participants |
| Wound Vac Application Including Irrigation | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement | Not Detected | 0 Participants |
| Wound Vac Application Including Irrigation | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement | Low | 1 Participants |
| Wound Vac Application Including Irrigation | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement | High | 1 Participants |
| Wound Vac Application Including Irrigation | Bio-burden as Measured by Qualitative Microbial PCR (Polymerase Chain Reaction) Prior to Second Debridement | Medium | 0 Participants |