Trial Outcomes & Findings for Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA (NCT NCT04712019)

NCT ID: NCT04712019

Last Updated: 2024-10-01

Results Overview

Percent change in lower limb volume as calculated using manual circumference measurements

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 5-7 days after bilateral TKA procedure
• Results posted on: 2024-10-01

Participant Flow

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.

Unit of analysis: Knee

Participant milestones

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Overall Study STARTED	10 10	10 10
Overall Study COMPLETED	7 7	7 7
Overall Study NOT COMPLETED	3 3	3 3

Reasons for withdrawal

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Overall Study Withdrawal by Subject	2	2
Overall Study Protocol required withdrawal - crossover treatment	1	1

Baseline Characteristics

Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA

Baseline characteristics by cohort

Measure	All Enrolled Subjects - Both Arms n=10 Participants This study was a split subject design. All subjects received both treatments - one on each knee.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
BMI	31.8 kg/m2 STANDARD_DEVIATION 6.57 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Percent change in lower limb volume as calculated using manual circumference measurements

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=9 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=9 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Percent Change in Lower Limb Volume	14.7 percentage of change in lower leg volume Standard Deviation 15.48	13.3 percentage of change in lower leg volume Standard Deviation 12.43

SECONDARY outcome

Timeframe: 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.

Percent change in lower limb volume as calculated using manual circumference measurements

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=8 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=8 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Percent Change in Lower Limb Volume	16.0 percentage of change in lower leg volume Standard Deviation 9.82	10.7 percentage of change in lower leg volume Standard Deviation 21.88

SECONDARY outcome

Timeframe: 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.

Percent change in lower limb volume as calculated using manual circumference measurements

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Percent Change in Lower Limb Volume	1.4 percentage of change in lower leg volume Standard Deviation 6.40	1.6 percentage of change in lower leg volume Standard Deviation 6.12

SECONDARY outcome

Timeframe: 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.

Percent change in lower limb volume as calculated using manual circumference measurements

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Percent Change in Lower Limb Volume	-1.3 percentage of change in lower leg volume Standard Deviation 9.58	-4.4 percentage of change in lower leg volume Standard Deviation 6.51

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=9 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=9 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Percent Change in Lower Limb Circumference 10cm above Patella	13.2 % change in lower leg circumference Standard Deviation 5.84	7.8 % change in lower leg circumference Standard Deviation 6.75
Percent Change in Lower Limb Circumference Center of Patella	7.7 % change in lower leg circumference Standard Deviation 11.23	6.4 % change in lower leg circumference Standard Deviation 7.89
Percent Change in Lower Limb Circumference 10cm below Patella	3.6 % change in lower leg circumference Standard Deviation 5.28	5.3 % change in lower leg circumference Standard Deviation 5.06
Percent Change in Lower Limb Circumference at the ankle, 1cm above medial malleolus	NA % change in lower leg circumference Standard Deviation NA Collected values were below the lower limit of qualification	NA % change in lower leg circumference Standard Deviation NA Collected values were below the lower limit of qualification

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=8 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=8 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Percent Change in Lower Limb Circumference 10cm above Patella	8.4 % change in lower leg circumference Standard Deviation 4.37	9.8 % change in lower leg circumference Standard Deviation 5.42
Percent Change in Lower Limb Circumference Center of Patella	12.8 % change in lower leg circumference Standard Deviation 5.03	2.2 % change in lower leg circumference Standard Deviation 25.01
Percent Change in Lower Limb Circumference 10cm below Patella	3.9 % change in lower leg circumference Standard Deviation 7.44	3.6 % change in lower leg circumference Standard Deviation 9.14
Percent Change in Lower Limb Circumference at the ankle, 1cm above medial malleolus	NA % change in lower leg circumference Standard Deviation NA Collected values were below the lower limit of qualification	NA % change in lower leg circumference Standard Deviation NA Collected values were below the lower limit of qualification

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Percent Change in Lower Limb Circumference 10cm above Patella	2.0 % change in lower leg circumference Standard Deviation 3.04	0.7 % change in lower leg circumference Standard Deviation 4.93
Percent Change in Lower Limb Circumference Center of Patella	1.9 % change in lower leg circumference Standard Deviation 4.24	3.0 % change in lower leg circumference Standard Deviation 3.15
Percent Change in Lower Limb Circumference 10cm below Patella	0.0 % change in lower leg circumference Standard Deviation 5.20	-0.9 % change in lower leg circumference Standard Deviation 5.96
Percent Change in Lower Limb Circumference at the ankle, 1cm above medial malleolus	NA % change in lower leg circumference Standard Deviation NA Collected values were below the lower limit of qualification	NA % change in lower leg circumference Standard Deviation NA Collected values were below the lower limit of qualification

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Percent Change in Lower Limb Circumference 10cm above Patella	0.1 % change in lower leg circumference Standard Deviation 5.38	-3.6 % change in lower leg circumference Standard Deviation 5.41
Percent Change in Lower Limb Circumference Center of Patella	-0.5 % change in lower leg circumference Standard Deviation 5.04	-0.3 % change in lower leg circumference Standard Deviation 2.65
Percent Change in Lower Limb Circumference 10cm below Patella	-0.9 % change in lower leg circumference Standard Deviation 7.44	-3.8 % change in lower leg circumference Standard Deviation 7.08
Percent Change in Lower Limb Circumference at the ankle, 1cm above medial malleolus	NA % change in lower leg circumference Standard Deviation NA Collected values were below the lower limit of qualification	NA % change in lower leg circumference Standard Deviation NA Collected values were below the lower limit of qualification

SECONDARY outcome

Timeframe: 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.

Change in knee flexion angle from baseline to Visit 3

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change in Knee Flexion Angle	-18.3 Degrees Standard Deviation 22.02	-19.9 Degrees Standard Deviation 17.39

SECONDARY outcome

Timeframe: 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.

Change in knee flexion angle from baseline to Visit 4

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change in Knee Flexion Angle	-10.7 Degrees Standard Deviation 25.36	-9.6 Degrees Standard Deviation 18.65

SECONDARY outcome

Timeframe: 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.

Change in knee flexion angle from baseline to Visit 5

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change in Knee Flexion Angle	0.0 Degrees Standard Deviation 21.98	1.0 Degrees Standard Deviation 11.42

SECONDARY outcome

Timeframe: 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.

Change in knee flexion angle from baseline to Visit 6

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change in Knee Flexion Angle	17.9 Degrees Standard Deviation 22.52	15.7 Degrees Standard Deviation 13.97

SECONDARY outcome

Timeframe: 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.

Change in knee extension angle from baseline to Visit 3

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change in Knee Extension Angle	-2.9 Degrees Standard Deviation 4.10	1.1 Degrees Standard Deviation 7.97

SECONDARY outcome

Timeframe: 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.

Change in knee extension angle from baseline to Visit 4

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change in Knee Extension Angle	9.0 Degrees Standard Deviation 26.95	2.3 Degrees Standard Deviation 6.24

SECONDARY outcome

Timeframe: 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.

Change in knee extension angle from baseline to Visit 5

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change in Knee Extension Angle	-2.4 Degrees Standard Deviation 3.36	1.6 Degrees Standard Deviation 6.40

SECONDARY outcome

Timeframe: 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.

Change in knee extension angle from baseline to Visit 6

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change in Knee Extension Angle	-2.9 Degrees Standard Deviation 7.76	0.3 Degrees Standard Deviation 9.25

SECONDARY outcome

Timeframe: 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.

Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 3

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change of Total Range of Motion in Degrees	-15.4 Degrees Standard Deviation 23.19	-21.0 Degrees Standard Deviation 20.12

SECONDARY outcome

Timeframe: 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.

Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 4

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change of Total Range of Motion in Degrees	-19.7 Degrees Standard Deviation 49.54	-11.9 Degrees Standard Deviation 21.80

SECONDARY outcome

Timeframe: 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.

Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 5

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change of Total Range of Motion in Degrees	2.4 Degrees Standard Deviation 24.96	-0.6 Degrees Standard Deviation 12.43

SECONDARY outcome

Timeframe: 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.

Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 6

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Change of Total Range of Motion in Degrees	20.7 Degrees Standard Deviation 28.40	15.4 Degrees Standard Deviation 19.01

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Incidence of Surgical Site Complications (SSCs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Incidence of Surgical Site Complications (SSCs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=7 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=7 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Scar Cosmesis Assessment	5.86 units on a scale Standard Deviation 1.069	6.43 units on a scale Standard Deviation 1.902

SECONDARY outcome

Timeframe: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure

Population: This is the full analysis set of available data

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.

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=2 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=2 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Average Pain in Each Leg in the Last 24 Hours	5.00 score on a scale Standard Deviation 4.243	5.00 score on a scale Standard Deviation 4.243

SECONDARY outcome

Timeframe: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure

Population: This is the full analysis set of available data

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.

Outcome measures

Measure	Closed Incision Negative Pressure Therapy (ciNPT) Dressing n=2 Participants Prevena Restor Arthro-Form Dressing with 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 at 125mmHg of continuous negative pressure on a closed surgical incision	Standard Silver-containing Dressing n=2 Participants Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision
Worst Pain in Each Leg in the Last 24 Hours	6.00 score on a scale Standard Deviation 4.243	5.50 score on a scale Standard Deviation 4.950

Adverse Events

All Enrolled Subjects - Both Arms

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Enrolled Subjects - Both Arms n=10 participants at risk Subjects who received both the Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit and Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	20.0% 2/10 • Number of events 2 • Adverse events were collected from the time of randomization through completion of the Visit 6 (77-91 days Post-op)

Other adverse events

Measure	All Enrolled Subjects - Both Arms n=10 participants at risk Subjects who received both the Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit and Standard Silver-containing Dressing: A standard silver-containing dressing applied to a closed surgical incision.
Skin and subcutaneous tissue disorders Blister	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of randomization through completion of the Visit 6 (77-91 days Post-op)
Vascular disorders Hypotension	10.0% 1/10 • Number of events 1 • Adverse events were collected from the time of randomization through completion of the Visit 6 (77-91 days Post-op)

Additional Information

Biostatistics Manager

3M

Phone: 651-382-2876

Email: swalters@mmm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60