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| Name | Class |
|---|---|
| Kinetic Concepts, Inc. | INDUSTRY |
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For the target population of adult patients following primary total hip arthroplasty, the randomized clinical trial will be used to evaluate the efficacy of the use of a mobile negative pressure wound therapy(NPWT) device compared to a standard absorptive dressing in the immediate postoperative period. We will apply two dressing types and evaluate the postoperative wounds with a wound scoring system (ASEPSIS) that incorporates multiple variables of wound infection risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREVENA Group | Experimental | Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. |
|
| Standard group | No Intervention | Patients will be treated with the standard absorptive dressing following total hip arthroplasty. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREVENA | Device | The device is a sealed negative pressure wound therapy tool. The device will be placed on the skin during surgery and left in place until their followup at 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Wound Healing Scores by the ASEPSIS Criteria | A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system. Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection. This includes dehiscence, exudate/discharge, and erythema. The higher the score, the more likely a surgical site infection will be present. This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy. Scores can range from 0 to 65, with most scores expected at the lower scale. | (Single point evaluation)-2 weeks post surgery visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Infection | The investigators will continue to monitor the patients for development of an acute postoperative infection. A deep infection refers to an infection below the superficial soft tissue and likely involving the prosthesis. This will be evaluated by the musculoskeletal infection society consensus on total joint infection. Criteria include:(Either one major criteria or four minor criteria) Major criteria Sinus track communicating with the prosthesis Two separate cultures from the joint positive for the same organism Minor criteria Elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) Elevated synovial leukocyte count Elevated synovial neutrophil percentage Purulent drainage from the joint One positive fluid culture from the joint Histological analysis of tissue showing more than 5 neutrophils per high power field in 5 fields |
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Inclusion Criteria:
- Adult patients undergoing primary total hip arthroplasty.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Del Gaizo, MD | UNC Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Orthopaedics | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| PREVENA website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PREVENA Group | Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery. |
| FG001 | Standard Group | Patients will be treated with the standard absorptive dressing following total hip arthroplasty. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PREVENA Group | Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Wound Healing Scores by the ASEPSIS Criteria | A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system. Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection. This includes dehiscence, exudate/discharge, and erythema. The higher the score, the more likely a surgical site infection will be present. This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy. Scores can range from 0 to 65, with most scores expected at the lower scale. | Measured outcomes for all patients that completed the treatment | Posted | Mean | Full Range | units on a scale | (Single point evaluation)-2 weeks post surgery visit |
|
Patients that enrolled in the study were followed and seen at 2 weeks postoperatively. The study was terminated prior to patients returning for their 6 week visit so they were not seen by the research staff after 2 weeks. All patients were followed by chart review to confirm adverse events within 6 months of enrolling in the study.
Personal examination at 2 weeks, chart review at 6 months.
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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 | PREVENA Group | Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound drainage | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Wound drainage for 2 weeks postoperatively requiring antibiotics |
Major Limitation-Study could not be completed due to the loss of research personnel early during the trial. We did not have the funding to provide for an additional personnel.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Eskildsen, MD | UNC Orthopaedics | (919) 966-9166 | seskilds@unch.unc.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 | Sep 18, 2014 | Feb 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| (Single point evaluation)-6 weeks post surgery visit |
| BG001 | Standard Group | Patients will be treated with the standard absorptive dressing following total hip arthroplasty. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Discharge location | Count of Participants | Participants |
|
| OG000 | PREVENA Group | Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. PREVENA: The device is a sealed negative pressure wound therapy tool. A single device is placed on the wound at the time of surgery. And removed at the time of the first postop visit around 7 days after surgery. |
| OG001 | Standard Group | Patients will be treated with the standard absorptive dressing following total hip arthroplasty. |
|
|
| Secondary | Number of Participants With Infection | The investigators will continue to monitor the patients for development of an acute postoperative infection. A deep infection refers to an infection below the superficial soft tissue and likely involving the prosthesis. This will be evaluated by the musculoskeletal infection society consensus on total joint infection. Criteria include:(Either one major criteria or four minor criteria) Major criteria Sinus track communicating with the prosthesis Two separate cultures from the joint positive for the same organism Minor criteria Elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) Elevated synovial leukocyte count Elevated synovial neutrophil percentage Purulent drainage from the joint One positive fluid culture from the joint Histological analysis of tissue showing more than 5 neutrophils per high power field in 5 fields | Measured all that enrolled and completed the treatment | Posted | Count of Participants | Participants | (Single point evaluation)-6 weeks post surgery visit |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Standard Group | Patients will be treated with the standard absorptive dressing following total hip arthroplasty. | 0 | 9 | 0 | 9 | 1 | 9 |
|
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