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VAC Bioburden Wound Care Assessment

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Duke University

Status

Terminated

Conditions

Upper Extremity Wound
Soft Tissue Abscesses
Traumatic Wounds
Lower Extremity Wound

Treatments

Device: Wound Vac is applied

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04826965
Pro00105056

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 2 patient groups

Wound vac application
Active Comparator group
Description:
Wound vac application for open upper/lower extremity open wound
Treatment:
Device: Wound Vac is applied
Wound vac application including irrigation
Active Comparator group
Description:
Wound vac application WITH irrigation for upper/lower extremity open wound
Treatment:
Device: Wound Vac is applied

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Suhail Mithani

Data sourced from clinicaltrials.gov

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