VAC Bioburden Wound Care Assessment

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-10-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Upper Extremity Wound Lower Extremity Wound Soft Tissue Abscesses Traumatic Wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Wound vac application

Wound vac application for open upper/lower extremity open wound

Group Type ACTIVE_COMPARATOR

Wound Vac is applied

Intervention Type DEVICE

A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.

Wound vac application including irrigation

Wound vac application WITH irrigation for upper/lower extremity open wound

Group Type ACTIVE_COMPARATOR

Wound Vac is applied

Intervention Type DEVICE

A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.

Interventions

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Wound Vac is applied

A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.

Intervention Type DEVICE

Eligibility Criteria

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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.