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| ID | Type | Description | Link |
|---|---|---|---|
| 1138438 |
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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| University of Alabama at Birmingham | OTHER |
| Medical College of Wisconsin | OTHER |
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The purpose of this research is to study the efficacy and cost effectiveness of the VAC device in comparison to traditional gauze wound dressing in pelvic, acetabular and hip fractures, specifically to see if there is a reduction in the incidence of post operative surgical wound drainage, infections, and hospital stay.
Soft tissue injuries are commonly associated with pelvic and acetabular injuries and additional tissue injury occurs during surgery. Post operative wound drainage, infections and prolonged hospital stay are a common problem during postoperative care. Traditional treatment is dressing of the surgical wound with different conventional dressings.
Use of negative pressure wound therapy has been shown to be beneficial in significantly decreasing wound drainage. Stannard et al. reported the results of randomizing 44 patients with lower extremity fractures (including 4 pilon fractures) into either receiving standard post operative dressing versus NPWT (negative pressure wound therapy). His results showed no difference in infection rate or wound breakdown, but did show a significant difference in the drainage time. The NPWT group stopped draining 3 days earlier than the standard dressing group. The use of NPWT has greatly increased over the years and has been an important adjunct to wound management. These results and anecdotal clinical experience with the use of NPWT (wound VAC) has led us to develop our research question; Does the use of incisional VAC following pelvic &/or acetabular surgery decrease wound complications.
The VAC (KCI USA) device is relatively new device that utilizes negative pressure as a treatment modality for soft tissue injuries following high velocity injuries. VAC device exerts intermittent or constant negative pressure and removes excess fluid from the interstitial space and increases perfusion through vessels. Previous VAC studies showed decreased bacterial load after applying VAC device to the infected wounds.
There have been no randomized studies to prove the cost effectiveness and efficacy of VAC device in reducing wound drainage, infections, and prolonged hospital stays in comparison to traditional gauze dressing wound management during post operative management of pelvic and acetabular fractures.
In examining the incidence of wound complications/infections, we can determine if the incisional VAC decreases the need for additional intervention and if there are any patient related factors (i.e. obesity) related to increased risk of wound complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAC Device placement | Experimental | will have the VAC device used for post-operative management of acetabular fractures and pelvic fractures. |
|
| Gauze dressing | Active Comparator | will receive current traditional surgical wound management with daily dressing changes in post operative management of acetabular fractures and pelvic fractures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAC device | Device | Vacuum Assisted Closure (VAC) device for surgical incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Wound Infections | Until wound healed, up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brett D Crist, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | VAC Device | Vacuum Assisted Closure (VAC) device Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision |
| FG001 | Gauze Dressing | Gauze Dressing Gauze dressing: Gauze dressing for surgical incision |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VAC Device | Vacuum Assisted Closure (VAC) device Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision |
| BG001 | Gauze Dressing | Gauze Dressing Gauze dressing: Gauze dressing for surgical incision |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Wound Infections | Posted | Number | participants | Until wound healed, up to 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 | VAC Device | Vacuum Assisted Closure (VAC) device Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection | Renal and urinary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Crist, MD | University of Missouri, Department of Orthopaedics | 573-882-6562 | cristb@health.missouri.edu |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Gauze dressing | Other | Gauze dressing for surgical incision |
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 15 |
| 49 |
| 3 |
| 49 |
| EG001 | Gauze Dressing | Gauze Dressing Gauze dressing: Gauze dressing for surgical incision | 9 | 42 | 5 | 42 |
| Perforated colon | Gastrointestinal disorders |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders |
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| CVA | Vascular disorders |
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| implant failure | Surgical and medical procedures |
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| prescription overdose | General disorders |
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| DVT | Vascular disorders |
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| PE | Vascular disorders |
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| ileus | Gastrointestinal disorders |
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| Regional Pain Syndrome | Nervous system disorders |
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| pneumomediastinum | Respiratory, thoracic and mediastinal disorders |
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| hematoma | Vascular disorders |
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| malignancy, unrelated | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| fall, no injury | General disorders |
|
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