Surgical Wound, Bilateral Total Knee Arthroplasty, Wounds and Injuries, Joint Diseases, Musculoskeletal Diseases, Edema Leg, Joint Pain, Arthritis Knee
Conditions
Brief summary
This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.
Interventions
Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision
DEVICEStandard Silver-containing Dressing
A standard silver-containing dressing applied to a closed surgical incision
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One leg receives ciNPT and the other leg receives standard silver containing dressing.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* is at least 22 years of age on the date of informed consent. * can independently provide informed consent. * requires and is scheduled to undergo a simultaneous, bilateral, primary TKA. * is willing and physically capable of undergoing a simultaneous, bilateral, primary TKA with or without replacement of the patella. * is willing and able to return for all scheduled study visits.
Exclusion criteria
* is pregnant or lactating. * has signs of an infection in the area of either knee or has signs of a systemic infection at the time of surgery. * is a chronic opioid user, defined per the CDC guidelines as opioid use for \>3 months, at the time of enrollment. * has a current diagnosis of lymphedema in either leg. * has signs, symptoms, or a current diagnosis of venous insufficiency in either leg, as determined by the investigator's review of the subject's medical history. * has a history of clotting disorder or prior history of deep vein thrombosis * will undergo a unilateral TKA. * will undergo a staged, bilateral TKA. * has had previous knee replacement surgery. * has received a corticosteroid injection into either knee within 30 days of surgery. * undergoes a simultaneous, bilateral TKA with a planned different incision type on each knee (eg, midline incision vs. medial parapatellar incision). * 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 enrolled in another interventional clinical study. * has skin cancer localized at or in proximity to the incision site. * does not have access to an electronic device (smartphone, iPad, or computer) on a daily basis to complete online assessments. * has condition(s) that, in the opinion of the investigator, cause the subject to be an overall health risk that is unsuitable for the surgery. * has condition(s) that, in the opinion of the investigator, will impact study endpoints (eg, hemophilia or autoimmune disorders) or the ability to comply with study procedures. Intra-Op
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Lower Limb Volume | 5-7 days after bilateral TKA procedure | Percent change in lower limb volume as calculated using manual circumference measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Lower Limb Circumference | 5-7 days after bilateral TKA procedure | Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella |
| Change in Knee Flexion Angle | 5-7 days after bilateral TKA procedure | Change in knee flexion angle from baseline to Visit 3 |
| Change in Knee Extension Angle | 5-7 days after bilateral TKA procedure | Change in knee extension angle from baseline to Visit 3 |
| Change of Total Range of Motion in Degrees | 5-7 days after bilateral TKA procedure | Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 3 |
| Percent Change in Lower Limb Volume | 12-14 days after bilateral TKA procedure | Percent change in lower limb volume as calculated using manual circumference measurements |
| Scar Cosmesis Assessment | Long Term Follow-up occurring 77-91 days after bilateral TKA procedure | Validated tool to assess the quality of postoperative scars in clinical and research settings. Scores range from 4 (best) to 14 (worst). Due to the lack of subjects and study data, only the value recorded at the final study visit was analyzed for each subject. The average score for each study arm was then calculated with the available data. |
| Average Pain in Each Leg in the Last 24 Hours | End of Treatment Visit occurring 12-14 days after bilateral TKA procedure | The average pain in each leg in the last 24 hours, using an NPRS (numerical pain rating scale) of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data. |
| Worst Pain in Each Leg in the Last 24 Hours | End of Treatment Visit occurring 12-14 days after bilateral TKA procedure | The worst pain in each leg in the last 24 hours, using an NPRS of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data. |
| Incidence of Surgical Site Complications (SSCs) | within 49 days of bilateral TKA procedure | Incidence of surgical site complications defined as: * 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 |
Countries
United States
Participant flow
Pre-assignment details
The number of subjects enrolled is 10; however, each leg is a separate arm in the study allowing for a total of 20 treatment allocations. The number started will be 20 which is greater than the protocol enrollment wherever this is acceptable for paired study design.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects - Both Arms This study was a split subject design. All subjects received both treatments - one on each knee. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol required withdrawal - crossover treatment | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | All Enrolled Subjects - Both Arms |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| BMI | 31.8 kg/m2 STANDARD_DEVIATION 6.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 2 / 10 |
Outcome results
Primary
Percent Change in Lower Limb Volume
Percent change in lower limb volume as calculated using manual circumference measurements
Time frame: 5-7 days after bilateral TKA procedure
Population: This is the full analysis set which excludes one subject who lacks data at the 5-7 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Volume | 14.7 percentage of change in lower leg volume | Standard Deviation 15.48 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Volume | 13.3 percentage of change in lower leg volume | Standard Deviation 12.43 |
Secondary
Average Pain in Each Leg in the Last 24 Hours
The average pain in each leg in the last 24 hours, using an NPRS (numerical pain rating scale) of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data.
Time frame: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure
Population: This is the full analysis set of available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Average Pain in Each Leg in the Last 24 Hours | 5.00 score on a scale | Standard Deviation 4.243 |
| Standard Silver-containing Dressing | Average Pain in Each Leg in the Last 24 Hours | 5.00 score on a scale | Standard Deviation 4.243 |
Secondary
Change in Knee Extension Angle
Change in knee extension angle from baseline to Visit 4
Time frame: 12-14 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 12-14 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change in Knee Extension Angle | 9.0 Degrees | Standard Deviation 26.95 |
| Standard Silver-containing Dressing | Change in Knee Extension Angle | 2.3 Degrees | Standard Deviation 6.24 |
Secondary
Change in Knee Extension Angle
Change in knee extension angle from baseline to Visit 3
Time frame: 5-7 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 5-7 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change in Knee Extension Angle | -2.9 Degrees | Standard Deviation 4.1 |
| Standard Silver-containing Dressing | Change in Knee Extension Angle | 1.1 Degrees | Standard Deviation 7.97 |
Secondary
Change in Knee Extension Angle
Change in knee extension angle from baseline to Visit 6
Time frame: 77-91 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 77-91 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change in Knee Extension Angle | -2.9 Degrees | Standard Deviation 7.76 |
| Standard Silver-containing Dressing | Change in Knee Extension Angle | 0.3 Degrees | Standard Deviation 9.25 |
Secondary
Change in Knee Extension Angle
Change in knee extension angle from baseline to Visit 5
Time frame: 35-49 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 35-49 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change in Knee Extension Angle | -2.4 Degrees | Standard Deviation 3.36 |
| Standard Silver-containing Dressing | Change in Knee Extension Angle | 1.6 Degrees | Standard Deviation 6.4 |
Secondary
Change in Knee Flexion Angle
Change in knee flexion angle from baseline to Visit 4
Time frame: 12-14 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 12-14 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change in Knee Flexion Angle | -10.7 Degrees | Standard Deviation 25.36 |
| Standard Silver-containing Dressing | Change in Knee Flexion Angle | -9.6 Degrees | Standard Deviation 18.65 |
Secondary
Change in Knee Flexion Angle
Change in knee flexion angle from baseline to Visit 3
Time frame: 5-7 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 5-7 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change in Knee Flexion Angle | -18.3 Degrees | Standard Deviation 22.02 |
| Standard Silver-containing Dressing | Change in Knee Flexion Angle | -19.9 Degrees | Standard Deviation 17.39 |
Secondary
Change in Knee Flexion Angle
Change in knee flexion angle from baseline to Visit 5
Time frame: 35-49 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 35-49 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change in Knee Flexion Angle | 0.0 Degrees | Standard Deviation 21.98 |
| Standard Silver-containing Dressing | Change in Knee Flexion Angle | 1.0 Degrees | Standard Deviation 11.42 |
Secondary
Change in Knee Flexion Angle
Change in knee flexion angle from baseline to Visit 6
Time frame: 77-91 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 77-91 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change in Knee Flexion Angle | 17.9 Degrees | Standard Deviation 22.52 |
| Standard Silver-containing Dressing | Change in Knee Flexion Angle | 15.7 Degrees | Standard Deviation 13.97 |
Secondary
Change of Total Range of Motion in Degrees
Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 3
Time frame: 5-7 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 5-7 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change of Total Range of Motion in Degrees | -15.4 Degrees | Standard Deviation 23.19 |
| Standard Silver-containing Dressing | Change of Total Range of Motion in Degrees | -21.0 Degrees | Standard Deviation 20.12 |
Secondary
Change of Total Range of Motion in Degrees
Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 4
Time frame: 12-14 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 12-14 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change of Total Range of Motion in Degrees | -19.7 Degrees | Standard Deviation 49.54 |
| Standard Silver-containing Dressing | Change of Total Range of Motion in Degrees | -11.9 Degrees | Standard Deviation 21.8 |
Secondary
Change of Total Range of Motion in Degrees
Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 6
Time frame: 77-91 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 77-91 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change of Total Range of Motion in Degrees | 20.7 Degrees | Standard Deviation 28.4 |
| Standard Silver-containing Dressing | Change of Total Range of Motion in Degrees | 15.4 Degrees | Standard Deviation 19.01 |
Secondary
Change of Total Range of Motion in Degrees
Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 5
Time frame: 35-49 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 35-49 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Change of Total Range of Motion in Degrees | 2.4 Degrees | Standard Deviation 24.96 |
| Standard Silver-containing Dressing | Change of Total Range of Motion in Degrees | -0.6 Degrees | Standard Deviation 12.43 |
Secondary
Incidence of Surgical Site Complications (SSCs)
Incidence of surgical site complications defined as: * 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 49 days of bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data as of Day 49.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Incidence of Surgical Site Complications (SSCs) | 0 Participants |
| Standard Silver-containing Dressing | Incidence of Surgical Site Complications (SSCs) | 0 Participants |
Secondary
Incidence of Surgical Site Complications (SSCs)
Incidence of surgical site complications defined as: * 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 91 days of bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data as of Day 91.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Incidence of Surgical Site Complications (SSCs) | 0 Participants |
| Standard Silver-containing Dressing | Incidence of Surgical Site Complications (SSCs) | 0 Participants |
Secondary
Percent Change in Lower Limb Circumference
Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella
Time frame: 12-14 days after bilateral TKA procedure
Population: This is the full analysis set which excludes two subjects who lack data at the 12-14 day visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | 10cm above Patella | 8.4 % change in lower leg circumference | Standard Deviation 4.37 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | Center of Patella | 12.8 % change in lower leg circumference | Standard Deviation 5.03 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | 10cm below Patella | 3.9 % change in lower leg circumference | Standard Deviation 7.44 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | at the ankle, 1cm above medial malleolus | NA % change in lower leg circumference | — |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | at the ankle, 1cm above medial malleolus | NA % change in lower leg circumference | — |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | 10cm above Patella | 9.8 % change in lower leg circumference | Standard Deviation 5.42 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | 10cm below Patella | 3.6 % change in lower leg circumference | Standard Deviation 9.14 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | Center of Patella | 2.2 % change in lower leg circumference | Standard Deviation 25.01 |
Secondary
Percent Change in Lower Limb Circumference
Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella
Time frame: 77-91 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 77-91 day visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | 10cm above Patella | 0.1 % change in lower leg circumference | Standard Deviation 5.38 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | Center of Patella | -0.5 % change in lower leg circumference | Standard Deviation 5.04 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | 10cm below Patella | -0.9 % change in lower leg circumference | Standard Deviation 7.44 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | at the ankle, 1cm above medial malleolus | NA % change in lower leg circumference | — |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | at the ankle, 1cm above medial malleolus | NA % change in lower leg circumference | — |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | 10cm above Patella | -3.6 % change in lower leg circumference | Standard Deviation 5.41 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | 10cm below Patella | -3.8 % change in lower leg circumference | Standard Deviation 7.08 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | Center of Patella | -0.3 % change in lower leg circumference | Standard Deviation 2.65 |
Secondary
Percent Change in Lower Limb Circumference
Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella
Time frame: 5-7 days after bilateral TKA procedure
Population: This is the full analysis set which excludes one subject who lacks data at the 5-7 day visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | 10cm above Patella | 13.2 % change in lower leg circumference | Standard Deviation 5.84 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | Center of Patella | 7.7 % change in lower leg circumference | Standard Deviation 11.23 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | 10cm below Patella | 3.6 % change in lower leg circumference | Standard Deviation 5.28 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | at the ankle, 1cm above medial malleolus | NA % change in lower leg circumference | — |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | at the ankle, 1cm above medial malleolus | NA % change in lower leg circumference | — |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | 10cm above Patella | 7.8 % change in lower leg circumference | Standard Deviation 6.75 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | 10cm below Patella | 5.3 % change in lower leg circumference | Standard Deviation 5.06 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | Center of Patella | 6.4 % change in lower leg circumference | Standard Deviation 7.89 |
Secondary
Percent Change in Lower Limb Circumference
Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella
Time frame: 35-49 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 35-49 day visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | 10cm below Patella | 0.0 % change in lower leg circumference | Standard Deviation 5.2 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | 10cm above Patella | 2.0 % change in lower leg circumference | Standard Deviation 3.04 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | Center of Patella | 1.9 % change in lower leg circumference | Standard Deviation 4.24 |
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Circumference | at the ankle, 1cm above medial malleolus | NA % change in lower leg circumference | — |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | Center of Patella | 3.0 % change in lower leg circumference | Standard Deviation 3.15 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | 10cm below Patella | -0.9 % change in lower leg circumference | Standard Deviation 5.96 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | 10cm above Patella | 0.7 % change in lower leg circumference | Standard Deviation 4.93 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Circumference | at the ankle, 1cm above medial malleolus | NA % change in lower leg circumference | — |
Secondary
Percent Change in Lower Limb Volume
Percent change in lower limb volume as calculated using manual circumference measurements
Time frame: 77-91 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 77-91 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Volume | -1.3 percentage of change in lower leg volume | Standard Deviation 9.58 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Volume | -4.4 percentage of change in lower leg volume | Standard Deviation 6.51 |
Secondary
Percent Change in Lower Limb Volume
Percent change in lower limb volume as calculated using manual circumference measurements
Time frame: 12-14 days after bilateral TKA procedure
Population: This is the full analysis set which excludes two subjects who lack data at the 12-14 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Volume | 16.0 percentage of change in lower leg volume | Standard Deviation 9.82 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Volume | 10.7 percentage of change in lower leg volume | Standard Deviation 21.88 |
Secondary
Percent Change in Lower Limb Volume
Percent change in lower limb volume as calculated using manual circumference measurements
Time frame: 35-49 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who lack data at the 35-49 day visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Percent Change in Lower Limb Volume | 1.4 percentage of change in lower leg volume | Standard Deviation 6.4 |
| Standard Silver-containing Dressing | Percent Change in Lower Limb Volume | 1.6 percentage of change in lower leg volume | Standard Deviation 6.12 |
Secondary
Scar Cosmesis Assessment
Validated tool to assess the quality of postoperative scars in clinical and research settings. Scores range from 4 (best) to 14 (worst). Due to the lack of subjects and study data, only the value recorded at the final study visit was analyzed for each subject. The average score for each study arm was then calculated with the available data.
Time frame: Long Term Follow-up occurring 77-91 days after bilateral TKA procedure
Population: This is the full analysis set which excludes three subjects who did not complete study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Scar Cosmesis Assessment | 5.86 units on a scale | Standard Deviation 1.069 |
| Standard Silver-containing Dressing | Scar Cosmesis Assessment | 6.43 units on a scale | Standard Deviation 1.902 |
Secondary
Worst Pain in Each Leg in the Last 24 Hours
The worst pain in each leg in the last 24 hours, using an NPRS of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data.
Time frame: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure
Population: This is the full analysis set of available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) Dressing | Worst Pain in Each Leg in the Last 24 Hours | 6.00 score on a scale | Standard Deviation 4.243 |
| Standard Silver-containing Dressing | Worst Pain in Each Leg in the Last 24 Hours | 5.50 score on a scale | Standard Deviation 4.95 |