Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Evaluate the Efficacy of Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds

Conditions
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Open Chest Wounds

Intervention / Treatment
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* Device: Wound Vacuum-assisted dressing
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vacuum-assisted dressing<br>Eligible subjects will receive negative pressure wound therapy during surgery. | Device: Wound Vacuum-assisted dressing<br>* 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).<br>* Other names: Wound Vacuum-assisted dressing (V-AD);|
| Other: Historical control group for comparison<br>Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques. | Other: Control group<br>* Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Negative Pressure Wound Therapy (NWPT) | The total number of days of receiving NWPT | 12 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure | The total number of days to wound closure | 12 months | 
| Length of Hospital Stay | The total number of days in hospital | 12 months |