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Slow accrual
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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wound vac application | Active Comparator | Wound vac application for open upper/lower extremity open wound |
|
| Wound vac application including irrigation | Active Comparator | Wound vac application WITH irrigation for upper/lower extremity open wound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound Vac is applied | Device | A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied. |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
- Patient with wounds distal to the ankle.
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| Name | Affiliation | Role |
|---|---|---|
| Suhail Mithani, MD | Duke Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Wound Vac Application Including Irrigation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Day 1 (day of first operative debridement) |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suhail Mithani, MD | Duke University | 919-681-8390 | suhail.mithani@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2022 | Oct 10, 2023 | Prot_SAP_000.pdf |
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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.
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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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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. |
|
|
| 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. | Posted | Count of Participants | Participants | Day 1 (day of first operative debridement) |
|
|
|
| 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. | Posted | Count of Participants | Participants | Day 2 (day of second operative debridement) |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
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| High |
|
| High |
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| Not Detected |
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