VAC Bioburden Wound Care Assessment

NCT04826965 | Terminated Results FDA Device

• 1 other identifier: Pro00105056
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Extremity Wound; Lower Extremity Wound; Soft Tissue Abscesses; Traumatic Wounds

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

Wound vac application

ACTIVE COMPARATOR

Wound vac application for open upper/lower extremity open wound

Device: Wound Vac is applied

Wound vac application including irrigation

ACTIVE COMPARATOR

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

Device: Wound Vac is applied

Interventions

Wound Vac is applied DEVICE

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

Wound vac application; Wound vac application including irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• +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.

You may not qualify if:

• \- Patient with wounds distal to the ankle.

Sponsors & Collaborators

• Duke University: lead
• 3M: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Suhail Mithani, MD
• Organization: Duke University

suhail.mithani@duke.edu

919-681-8390

Study Officials

• Suhail Mithani, MD

  Duke Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: August 1, 2021
• Primary Completion: October 13, 2022
• Study Completion: October 13, 2022
• Last Updated: November 3, 2023
• Results First Posted: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)