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| ID | Type | Description | Link |
|---|---|---|---|
| IRB#13-033 | Other Identifier | ProMedica Institutional Review Board |
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Determine the extent to which application of the Prevena vacuum system to clean surgical incisions immediately following surgical procedure (total hip or total knee arthroplasty) will reduce the rates of:
The specific aim of this research project is to determine the effect of using the Prevena vacuum system on the rate of repeat surgical procedures and surgical site complications in patients having undergone a total knee or hip arthroplasty. It is believed that negative pressure wound therapy is effective in the promotion of healing of complicated, non-healing, and infected wounds in many settings. In light of this existing evidence, the investigators believe that applying negative pressure wound therapy to clean incisions, in the orthopedic setting, before infection or complication occur may prevent complications and lower overall cost of care for patients undergoing total hip or knee arthroplasty.
The investigators' primary hypothesis is that application of the Prevena vacuum system to a clean incision in the operating room for patients who have undergone a total knee arthroplasty or hip replacement surgery will reduce the occurrence of repeat surgeries when the system remains in place and functional for seven days following its application. Prevena is the ideal system for this patient population because it is best suited for non-draining wounds; hip and knee arthroplasties result most often in non-draining wounds, which evidence suggests are less likely to become infected and cause other complications.
Secondary hypotheses to be tested in this study are that the application and use of the Prevena vacuum system in patients who have undergone a total knee arthroplasty or hip replacement surgery will reduce the occurrence of seromas, hematomas, and will also reduce the occurrence of surgical site infections when the system remains in place and functional for seven days after application. Additionally, the investigators wish to compare the level of pain experienced by patients who use the Prevena system after surgery in comparison to those whose incision sites are covered with traditional dressings. The investigators hypothesize that patients whose wounds are dressed with the Prevena system will experience less pain than patients whose wounds are dressed with traditional dressings, which may be quite bulky and carry the risk of tape trauma injury. Finally, the investigators hypothesize that because the Prevena system will prevent surgical site complications that may lead to repeat procedures, the cost of treating patients with Prevena will be lower than the total relative cost of treating the patients whose wounds are dressed with traditional dressings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound. | |
| Prevena Knee/Hip | Experimental | Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena Incision Management System | Device | Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hospital Readmissions | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Infection | 60 days | |
| Number of Participants With Seroma | 60 days | |
| Number of Participants With Hematoma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Beer, MD | ProMedica Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wildwood Orthopaedic and Spine Hospital | Toledo | Ohio | 43615 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28705547 | Derived | Redfern RE, Cameron-Ruetz C, O'Drobinak SK, Chen JT, Beer KJ. Closed Incision Negative Pressure Therapy Effects on Postoperative Infection and Surgical Site Complication After Total Hip and Knee Arthroplasty. J Arthroplasty. 2017 Nov;32(11):3333-3339. doi: 10.1016/j.arth.2017.06.019. Epub 2017 Jun 17. |
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Patients were consented at time of surgery scheduling up to six months in advance of surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound. |
| FG001 | Prevena Hip/Knee | Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasy and receiving Prevena Incision Management System on the clean surgical wound. Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days. Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound. |
| BG001 | Prevena Hip/Knee |
| 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 Hospital Readmissions | Posted | Count of Participants | Participants | 60 days |
|
6 weeks postoperatively
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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 | Control | Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other reactions | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karl J. Beer, MD | ProMedica | 419-578-4260 | karl.beer@promedica.org |
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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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|
|
| 60 days |
Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound.
Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.
Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Infection | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Secondary | Number of Participants With Seroma | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Secondary | Number of Participants With Hematoma | Posted | Count of Participants | Participants | 60 days |
|
|
|
| 0 |
| 400 |
| 9 |
| 400 |
| EG001 | Prevena Hip/Knee | Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasy and receiving Prevena Incision Management System on the clean surgical wound. Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days. Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days. | 0 | 196 | 27 | 196 |
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