An interventional study of Wound Vac is applied in Upper Extremity Wound, Lower Extremity Wound and Soft Tissue Abscesses, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.
Sponsored by Duke University · Not applicable, Interventional, and Other
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 5 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Wound vac application for open upper/lower extremity open wound
Device: Wound Vac is applied
Wound vac application WITH irrigation for upper/lower extremity open wound
Device: Wound Vac is applied
A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
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)
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)
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)
| Milestone | Wound Vac Application | Wound Vac Application Including Irrigation |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
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.
| Participants | Wound Vac Application | Wound Vac Application Including Irrigation |
|---|---|---|
| Low | 0 | 0 |
| Medium | 1 | 1 |
| High | 2 | 1 |
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.
| Participants | Wound Vac Application | Wound Vac Application Including Irrigation |
|---|---|---|
| Low | 1 | 1 |
| Medium | 1 | 1 |
| High | 1 | 0 |
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.
| Participants | Wound Vac Application | Wound Vac Application Including Irrigation |
|---|---|---|
| Low | 1 | 1 |
| Medium | 1 | 0 |
| High | 0 | 1 |
| Not Detected | 1 | 0 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wound Vac Application | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Wound Vac Application Including Irrigation | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Wound Vac Application | Wound Vac Application Including Irrigation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 1 | 4 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Wound Vac Application | Wound Vac Application Including Irrigation | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 2 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Wound Vac Application | Wound Vac Application Including Irrigation | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 2 | 4 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Wound Vac Application | Wound Vac Application Including Irrigation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 1 | 2 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Wound Vac Application | Wound Vac Application Including Irrigation | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
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