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?

Status Terminated

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04826965
• Study type: Interventional
• Source: Duke University
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2021
• Completion date: October 13, 2022