VAC Bioburden Wound Care Assessment
Primary Purpose
Upper Extremity Wound, Lower Extremity Wound, Soft Tissue Abscesses
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wound Vac is applied
Sponsored by
About this trial
This is an interventional other trial for Upper Extremity Wound
Eligibility Criteria
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.
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Wound vac application
Wound vac application including irrigation
Arm Description
Wound vac application for open upper/lower extremity open wound
Wound vac application WITH irrigation for upper/lower extremity open wound
Outcomes
Primary Outcome Measures
Change in bio-burden as measured by quantitative microbial PCR
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04826965
First Posted
March 30, 2021
Last Updated
August 16, 2023
Sponsor
Duke University
Collaborators
3M
1. Study Identification
Unique Protocol Identification Number
NCT04826965
Brief Title
VAC Bioburden Wound Care Assessment
Official Title
Does Negative Pressure Wound Therapy With Instillation Reduce the Bioburden of Infections of the Upper and Lower Extremity?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
October 13, 2022 (Actual)
Study Completion Date
October 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
3M
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Wound, Lower Extremity Wound, Soft Tissue Abscesses, Traumatic Wounds
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wound vac application
Arm Type
Active Comparator
Arm Description
Wound vac application for open upper/lower extremity open wound
Arm Title
Wound vac application including irrigation
Arm Type
Active Comparator
Arm Description
Wound vac application WITH irrigation for upper/lower extremity open wound
Intervention Type
Device
Intervention Name(s)
Wound Vac is applied
Intervention Description
A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
Primary Outcome Measure Information:
Title
Change in bio-burden as measured by quantitative microbial PCR
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.
Time Frame
Enrollment - 3 months post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suhail Mithani, MD
Organizational Affiliation
Duke Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VAC Bioburden Wound Care Assessment
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