VAC Bioburden Wound Care Assessment

Lower Extremity Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04826965
• Other study ID #: Pro00105056
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: October 13, 2022

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 13, 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Extremity Wound
• Soft Tissue Abscesses
• Traumatic Wounds
• Upper Extremity Wound
• Wounds and Injuries

Intervention

Device:
• Wound Vac is applied
A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1 (day of first operative debridement)
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.	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.	Day 2 (day of second operative debridement)