Back to resultsVacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds
Primary Purpose
Open Chest Wounds
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wound Vacuum-assisted dressing
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Open Chest Wounds
Eligibility Criteria
Inclusion Criteria:
- Subject is scheduled to undergo surgical intervention(s) as part of the standard care for management of intra-thoracic infection.
Exclusion Criteria:
- Patent bronchopleural fistulas. Severe respiratory failure requiring mechanical ventilation at the time of first consultation.
- Proven or suspected malignancy in the wound. Coagulopathy due to medical or pharmacologic reasons. Dependency on anticoagulants or antiplatelet medication due to high risk for adverse events if these medications are stopped for a prolonged period of time.
Allergy to acrylic products.
Sites / Locations
- Mauricia Buchanan
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Vacuum-assisted dressing
Historical control group for comparison
Arm Description
Eligible subjects will receive negative pressure wound therapy during surgery.
Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
Outcomes
Primary Outcome Measures
Duration of Negative Pressure Wound Therapy (NWPT)
The total number of days of receiving NWPT
Secondary Outcome Measures
Wound Closure
The total number of days to wound closure
Length of Hospital Stay
The total number of days in hospital
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02803164
Brief Title
Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds
Official Title
A Pilot Study to Evaluate the Efficacy of Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
November 3, 2020 (Actual)
Study Completion Date
November 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds (OCW) and will decrease the time-to-closure of such wounds when compared to a historical cohort of patients managed by traditional wound care management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Chest Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vacuum-assisted dressing
Arm Type
Other
Arm Description
Eligible subjects will receive negative pressure wound therapy during surgery.
Arm Title
Historical control group for comparison
Arm Type
Other
Arm Description
Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
Intervention Type
Device
Intervention Name(s)
Wound Vacuum-assisted dressing
Other Intervention Name(s)
Wound Vacuum-assisted dressing (V-AD)
Intervention Description
The NPWT system (V.A.C. Therapy System, KCI USA Inc.) consisted of a medical-grade non-adherent polyvinyl alcohol white foam applied directly to the infected surface, followed by an open-pore reticulated polyurethane black foam cut to fit the wound and covered by a transparent air-tight adhesive drape. A suction cup with tubing was placed over a small slit on the drape and connected to a suction machine (V.A.C. ULTA Therapy Unit).
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
Primary Outcome Measure Information:
Title
Duration of Negative Pressure Wound Therapy (NWPT)
Description
The total number of days of receiving NWPT
Time Frame
12 month follow up
Secondary Outcome Measure Information:
Title
Wound Closure
Description
The total number of days to wound closure
Time Frame
12 months
Title
Length of Hospital Stay
Description
The total number of days in hospital
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is scheduled to undergo surgical intervention(s) as part of the standard care for management of intra-thoracic infection.
Exclusion Criteria:
Patent bronchopleural fistulas. Severe respiratory failure requiring mechanical ventilation at the time of first consultation.
Proven or suspected malignancy in the wound. Coagulopathy due to medical or pharmacologic reasons. Dependency on anticoagulants or antiplatelet medication due to high risk for adverse events if these medications are stopped for a prolonged period of time.
Allergy to acrylic products.
Facility Information:
Facility Name
Mauricia Buchanan
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
URL
https://www.liebertpub.com/doi/10.1089/sur.2020.397
Description
Published manuscript
Learn more about this trial
Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds
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