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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacuum-assisted dressing | Other | Eligible subjects will receive negative pressure wound therapy during surgery. |
|
| Historical control group for comparison | Other | Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound Vacuum-assisted dressing | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Negative Pressure Wound Therapy (NWPT) | The total number of days of receiving NWPT | 12 month follow up |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Allergy to acrylic products.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mauricia Buchanan | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Treatment of wound with Vacuum-assisted dressing. Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing. |
| FG001 | Historical Control | Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
21 completed
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Treatment of wound with Vacuum-assisted dressing. Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Negative Pressure Wound Therapy (NWPT) | The total number of days of receiving NWPT | Data not collected or analyzed for the Historical Control arm. This arm did not receive the NWPT. | Posted | Median | Full Range | Days | 12 month follow up |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Treatment of wound with Vacuum-assisted dressing. Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mathew Thomas | Mayo Clinic | 904-953-2000 | thomas.mathew@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2018 | Aug 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
|
| Control group | Other | Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques. |
|
Historical chest wound treatment.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Wound Closure | The total number of days to wound closure | Posted | Median | Full Range | Days | 12 months |
|
|
|
| Secondary | Length of Hospital Stay | The total number of days in hospital | Posted | Median | Full Range | Days | 12 months |
|
|
|
| 2 |
| 10 |
| 2 |
| 10 |
| 2 |
| 10 |
| EG001 | Historical Control | Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques | 1 | 11 | 11 | 11 | 8 | 11 |
| Major cardiac event | Cardiac disorders | Systematic Assessment |
|
| Air Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Reintubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute kidney failure | Renal and urinary disorders | Systematic Assessment |
|
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Wound dehiscence | General disorders | Systematic Assessment |
|
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| D008722 | Methods |