Complications; Arthroplasty, Infection or Inflammation, Wound Complication
Conditions
Brief summary
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.
Interventions
DEVICEPREVENA
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.
Sponsors
Kinetic Concepts, Inc.
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Adult patients undergoing primary total hip arthroplasty.
Exclusion criteria
* age less than 18 y/o * Total hip arthroplasty for fracture * Revision or conversion total hip arthroplasty * inability to personally consent to participation due to cognitive impairment, intoxication or sedation * multiple surgical procedures * Patients taking immune modulating medication(prednisone, methotrexate, anakinra, etc.) * skin hypersensitivity to acrylic adhesive or silver. * Inability to care for dressing due to physical or mental incapacitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Wound Healing Scores by the ASEPSIS Criteria | (Single point evaluation)-2 weeks post surgery visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Infection | (Single point evaluation)-6 weeks post surgery visit | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| Standard Group Patients will be treated with the standard absorptive dressing following total hip arthroplasty. | 9 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Loss of Research Personnel | 7 | 9 |
Baseline characteristics
| Characteristic | PREVENA Group | Standard Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Continuous | 54.6 years | 57.6 years | 56.2 years |
| Discharge location Home | 5 Participants | 6 Participants | 11 Participants |
| Discharge location Skilled Nursing Facility | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 9 |
| other Total, other adverse events | 0 / 7 | 1 / 9 |
| serious Total, serious adverse events | 0 / 7 | 0 / 9 |
Outcome results
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.
Time frame: (Single point evaluation)-2 weeks post surgery visit
Population: Measured outcomes for all patients that completed the treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PREVENA Group | Mean Wound Healing Scores by the ASEPSIS Criteria | 0.57 units on a scale |
| Standard Group | Mean Wound Healing Scores by the ASEPSIS Criteria | 1.66 units on a scale |
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
Time frame: (Single point evaluation)-6 weeks post surgery visit
Population: Measured all that enrolled and completed the treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PREVENA Group | Number of Participants With Infection | Deep Infection | 0 Participants |
| PREVENA Group | Number of Participants With Infection | No deep infection | 7 Participants |
| Standard Group | Number of Participants With Infection | Deep Infection | 0 Participants |
| Standard Group | Number of Participants With Infection | No deep infection | 9 Participants |