VAC Bioburden Wound Care Assessment

Not Applicable

Terminated

• Conditions: Traumatic Wounds; Lower Extremity Wound; Upper Extremity Wound; Soft Tissue Abscesses
• Interventions: Device: Wound Vac is applied

• Registration Number: NCT04826965
• Lead Sponsor: Duke University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Study Start: 2021-08-01
• Primary Completion: 2022-10-13
• Study Completion: 2022-10-13
• Status Verified: 2023-10
• Results First Submitted: 2023-10-10
• Results First Submitted QC: 2023-10-10
• Last Update Submitted: 2023-10-10
• Results First Posted: 2023-11-03
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

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Exclusion Criteria

• Patient with wounds distal to the ankle.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound vac application	Wound Vac is applied	Wound vac application for open upper/lower extremity open wound
Wound vac application including irrigation	Wound Vac is applied	Wound vac application WITH irrigation for upper/lower extremity open wound

Primary Outcome Measures

Name	Time	Method
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 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) 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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States