Surgical Wound, Revision Total Knee Arthroplasty, Wounds and Injuries, Joint Disease, Musculoskeletal Disease, Prosthesis-Related Infections, Infection, Postoperative Complications, Pathologic Processes
Conditions
Brief summary
This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care dressing.
Interventions
Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.
A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Sponsors
3M
KCI USA, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pre-operative Inclusion Criteria: The subject: * is at least 22 years of age on the date of informed consent * is able to provide their own informed consent * requires a TKA revision defined as one of the following: 1. a one-stage aseptic revision procedure 2. a one-stage septic exchange procedure (requiring removal of all hardware) for acute postoperative infection 3. removal of cement spacer and re-implantation procedure 4. open reduction and internal fixation of peri-prosthetic fractures * has one or more of the following: 1. a body mass index (BMI) greater than 35 kg/m2 2. a requirement for the use of blood thinners other than acetylsalicylic acid (ASA) after surgery 3. history of or current peripheral vascular disease 4. the presence of lymphedema in the operative limb 5. insulin-dependent diabetes mellitus 6. current tobacco use or previous history of smoking and quitting within the past 30 days 7. a history of prior infection of the operative site 8. current use of immunomodulators or steroids 9. current or history of cancer or hematological malignancy (excluding localized skin cancer) 10. rheumatoid arthritis 11. current renal failure or dialysis 12. malnutrition as determined by the investigator 13. liver disease as determined by the investigator 14. status post solid organ transplant 15. HIV * is willing and able to return for all scheduled study visits * if female, has a negative urine or serum pregnancy test at screening and day of revision surgery. Women who have had surgical sterilization by a medically accepted method such as tubal ligation, hysterectomy, or oophorectomy or are post-menopausal, defined as not having menstruation for \>= 12 months will be excluded from requiring this test. Intra-operative Inclusion Criteria: The subject: * continues to meet all pre-operative inclusion criteria * has undergone a TKA revision resulting in a closed surgical incision Pre-operative
Exclusion criteria
The subject: * is pregnant or lactating * will undergo a bilateral TKA within the same operative visit * will undergo a bilateral TKA in which the first TKA surgery is on the knee selected for study * will undergo a staged bilateral TKA in which the TKA revision surgery for the knee under study occurs within 30 days of the first TKA procedure * was previously randomized in this protocol * has a systemic active infection at the time of revision not including chronic viral infections such as HIV or hepatitis * has a remote-site skin infection at the time of revision * was tattooed on the area of the incision within 30 days prior to randomization * has known sensitivity to the study product components (drape and/or dressing materials in direct contact with the closed incision or skin) * has known sensitivity to silver * is currently enrolled in another investigational trial that requires additional interventions * is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study * has localized skin cancer around the incision site Intra-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Complications (SSC) | within 90 days after TKA revision | The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the following: * Superficial Surgical Site Infection (SSI) * Deep SSI * Full thickness skin dehiscence * Seroma or hematoma requiring drainage or surgery * Skin necrosis * Continued drainage at the time of dressing removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep) | 90 days after TKA revision | 90 day subject incidence of any SSI (superficial or deep) |
| Number of Participants With Deep Surgical Site Infection | 90 days after TKA revision | 90 day subject incidence of deep surgical site infection |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Complication (SSC) | within 90 days after TKA revision | The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the the following: * Superficial Surgical Site Infection (SSI) * Deep SSI * Full thickness skin dehiscence * Seroma or hematoma requiring drainage or surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit
Closed Incision Negative Pressure Therapy (ciNPT): Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days. | 147 |
| Standard of Care Dressing Silver impregnated dressing
Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively. | 147 |
| Total | 294 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Lost to Follow-up | 5 | 7 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Specified Withdrawal | 5 | 11 |
| Overall Study | Protocol Violation | 3 | 3 |
| Overall Study | Subject Non-compliance | 0 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 3 |
Baseline characteristics
| Characteristic | Closed Incision Negative Pressure Therapy (ciNPT) | Total | Standard of Care Dressing |
|---|---|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 9.48 | 64.9 years STANDARD_DEVIATION 9 | 65.1 years STANDARD_DEVIATION 8.51 |
| Body Mass Index | 34.7 kg/m^2 STANDARD_DEVIATION 6.73 | 34.5 kg/m^2 STANDARD_DEVIATION 6.96 | 34.2 kg/m^2 STANDARD_DEVIATION 7.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 20 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 125 Participants | 259 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 15 Participants | 7 Participants |
| Height | 169.8 centimeters STANDARD_DEVIATION 10.39 | 169.1 centimeters STANDARD_DEVIATION 10.49 | 168.3 centimeters STANDARD_DEVIATION 10.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 44 Participants | 94 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 91 Participants | 179 Participants | 88 Participants |
| Region of Enrollment United States | 147 participants | 294 participants | 147 participants |
| Sex: Female, Male Female | 83 Participants | 175 Participants | 92 Participants |
| Sex: Female, Male Male | 64 Participants | 119 Participants | 55 Participants |
| Weight | 100.4 kilograms STANDARD_DEVIATION 21.79 | 98.5 kilograms STANDARD_DEVIATION 21.98 | 96.6 kilograms STANDARD_DEVIATION 22.08 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 149 | 0 / 140 |
| other Total, other adverse events | 24 / 149 | 24 / 140 |
| serious Total, serious adverse events | 17 / 149 | 23 / 140 |
Outcome results
Primary
Number of Participants With Surgical Site Complications (SSC)
The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the following: * Superficial Surgical Site Infection (SSI) * Deep SSI * Full thickness skin dehiscence * Seroma or hematoma requiring drainage or surgery * Skin necrosis * Continued drainage at the time of dressing removal
Time frame: within 90 days after TKA revision
Population: Modified Intent-To-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) | Number of Participants With Surgical Site Complications (SSC) | 5 Participants |
| Standard of Care Dressing | Number of Participants With Surgical Site Complications (SSC) | 21 Participants |
p-value: 0.001395% CI: [0.08, 0.59]Cochran-Mantel-Haenszel
Secondary
Number of Participants With Deep Surgical Site Infection
90 day subject incidence of deep surgical site infection
Time frame: 90 days after TKA revision
Population: Modified Intent-To-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) | Number of Participants With Deep Surgical Site Infection | 1 Participants |
| Standard of Care Dressing | Number of Participants With Deep Surgical Site Infection | 3 Participants |
p-value: 0.338695% CI: [0.04, 3.39]Cochran-Mantel-Haenszel
Secondary
Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)
90 day subject incidence of any SSI (superficial or deep)
Time frame: 90 days after TKA revision
Population: Modified Intent-To-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) | Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep) | 2 Participants |
| Standard of Care Dressing | Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep) | 6 Participants |
p-value: 0.16895% CI: [0.07, 1.7]Cochran-Mantel-Haenszel
Other Pre-specified
Number of Participants With Surgical Site Complication (SSC)
The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the the following: * Superficial Surgical Site Infection (SSI) * Deep SSI * Full thickness skin dehiscence * Seroma or hematoma requiring drainage or surgery
Time frame: within 90 days after TKA revision
Population: Intent-To-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) | Number of Participants With Surgical Site Complication (SSC) | 5 Participants |
| Standard of Care Dressing | Number of Participants With Surgical Site Complication (SSC) | 21 Participants |
Comparison: Sensitivity analysis of the Primary Endpoint using the Intent-To-Treat population.p-value: 0.001395% CI: [0.08, 0.59]Cochran-Mantel-Haenszel