Trial Outcomes & Findings for Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty (NCT NCT03274466)

Last Updated: 2024-10-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

294 participants

Primary outcome timeframe

within 90 days after TKA revision

Results posted on

2024-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	147	147
Overall Study COMPLETED	124	118
Overall Study NOT COMPLETED	23	29

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	7	3
Overall Study Protocol Specified Withdrawal	5	11
Overall Study Lost to Follow-up	5	7
Overall Study Subject Non-compliance	0	1
Overall Study Adverse Event	3	3
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	3	3

Baseline Characteristics

Data missing from 1 subject.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Closed Incision Negative Pressure Therapy (ciNPT) n=147 Participants 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.	Standard of Care Dressing n=147 Participants Silver impregnated dressing Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.	Total n=294 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 9.48 • n=147 Participants	65.1 years STANDARD_DEVIATION 8.51 • n=147 Participants	64.9 years STANDARD_DEVIATION 9.00 • n=294 Participants
Sex: Female, Male Female	83 Participants n=147 Participants	92 Participants n=147 Participants	175 Participants n=294 Participants
Sex: Female, Male Male	64 Participants n=147 Participants	55 Participants n=147 Participants	119 Participants n=294 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=147 Participants	6 Participants n=147 Participants	20 Participants n=294 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	125 Participants n=147 Participants	134 Participants n=147 Participants	259 Participants n=294 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=147 Participants	7 Participants n=147 Participants	15 Participants n=294 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=147 Participants	0 Participants n=147 Participants	0 Participants n=294 Participants
Race (NIH/OMB) Asian	0 Participants n=147 Participants	1 Participants n=147 Participants	1 Participants n=294 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=147 Participants	0 Participants n=147 Participants	1 Participants n=294 Participants
Race (NIH/OMB) Black or African American	44 Participants n=147 Participants	50 Participants n=147 Participants	94 Participants n=294 Participants
Race (NIH/OMB) White	91 Participants n=147 Participants	88 Participants n=147 Participants	179 Participants n=294 Participants
Race (NIH/OMB) More than one race	10 Participants n=147 Participants	8 Participants n=147 Participants	18 Participants n=294 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=147 Participants	0 Participants n=147 Participants	1 Participants n=294 Participants
Region of Enrollment United States	147 participants n=147 Participants	147 participants n=147 Participants	294 participants n=294 Participants
Height	169.8 centimeters STANDARD_DEVIATION 10.39 • n=147 Participants • Data missing from 1 subject.	168.3 centimeters STANDARD_DEVIATION 10.58 • n=146 Participants • Data missing from 1 subject.	169.1 centimeters STANDARD_DEVIATION 10.49 • n=293 Participants • Data missing from 1 subject.
Weight	100.4 kilograms STANDARD_DEVIATION 21.79 • n=147 Participants	96.6 kilograms STANDARD_DEVIATION 22.08 • n=147 Participants	98.5 kilograms STANDARD_DEVIATION 21.98 • n=294 Participants
Body Mass Index	34.7 kg/m^2 STANDARD_DEVIATION 6.73 • n=147 Participants • Data missing for 1 subject.	34.2 kg/m^2 STANDARD_DEVIATION 7.18 • n=146 Participants • Data missing for 1 subject.	34.5 kg/m^2 STANDARD_DEVIATION 6.96 • n=293 Participants • Data missing for 1 subject.

PRIMARY outcome

Timeframe: within 90 days after TKA revision

Population: Modified Intent-To-Treat

Outcome measures

Outcome measures
Measure	Closed Incision Negative Pressure Therapy (ciNPT) n=125 Participants 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.	Standard of Care Dressing n=128 Participants Silver impregnated dressing Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Number of Participants With Surgical Site Complications (SSC)	5 Participants	21 Participants

SECONDARY outcome

Timeframe: 90 days after TKA revision

Population: Modified Intent-To-Treat

90 day subject incidence of any SSI (superficial or deep)

Outcome measures

Outcome measures
Measure	Closed Incision Negative Pressure Therapy (ciNPT) n=125 Participants 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.	Standard of Care Dressing n=128 Participants Silver impregnated dressing Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)	2 Participants	6 Participants

SECONDARY outcome

Timeframe: 90 days after TKA revision

Population: Modified Intent-To-Treat

90 day subject incidence of deep surgical site infection

Outcome measures

Outcome measures
Measure	Closed Incision Negative Pressure Therapy (ciNPT) n=125 Participants 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.	Standard of Care Dressing n=128 Participants Silver impregnated dressing Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Number of Participants With Deep Surgical Site Infection	1 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: within 90 days after TKA revision

Population: Intent-To-Treat

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

Outcome measures

Outcome measures
Measure	Closed Incision Negative Pressure Therapy (ciNPT) n=147 Participants 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.	Standard of Care Dressing n=147 Participants Silver impregnated dressing Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Number of Participants With Surgical Site Complication (SSC)	5 Participants	21 Participants

Adverse Events

Closed Incision Negative Pressure Therapy (ciNPT)

Serious events: 17 serious events

Other events: 24 other events

Deaths: 1 deaths

Standard of Care Dressing

Serious events: 23 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Closed Incision Negative Pressure Therapy (ciNPT) n=149 participants at risk 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.	Standard of Care Dressing n=140 participants at risk Silver impregnated dressing Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Injury, poisoning and procedural complications Blister	5.4% 8/149 • Number of events 8 • 104 days The Safety Population was utilized for reporting purposes. The Safety Population includes all randomized subjects with at least 1 application of study treatment. Subjects that were randomized but did not receive application of study treatment were withdrawn from the study and therefore not included in the Safety Population. Subjects in the Safety Population were counted under the treatment received irrespective of the assigned treatment.	0.71% 1/140 • Number of events 1 • 104 days The Safety Population was utilized for reporting purposes. The Safety Population includes all randomized subjects with at least 1 application of study treatment. Subjects that were randomized but did not receive application of study treatment were withdrawn from the study and therefore not included in the Safety Population. Subjects in the Safety Population were counted under the treatment received irrespective of the assigned treatment.
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 9/149 • Number of events 9 • 104 days The Safety Population was utilized for reporting purposes. The Safety Population includes all randomized subjects with at least 1 application of study treatment. Subjects that were randomized but did not receive application of study treatment were withdrawn from the study and therefore not included in the Safety Population. Subjects in the Safety Population were counted under the treatment received irrespective of the assigned treatment.	5.0% 7/140 • Number of events 7 • 104 days The Safety Population was utilized for reporting purposes. The Safety Population includes all randomized subjects with at least 1 application of study treatment. Subjects that were randomized but did not receive application of study treatment were withdrawn from the study and therefore not included in the Safety Population. Subjects in the Safety Population were counted under the treatment received irrespective of the assigned treatment.
Surgical and medical procedures Wound Drainage	5.4% 8/149 • Number of events 8 • 104 days The Safety Population was utilized for reporting purposes. The Safety Population includes all randomized subjects with at least 1 application of study treatment. Subjects that were randomized but did not receive application of study treatment were withdrawn from the study and therefore not included in the Safety Population. Subjects in the Safety Population were counted under the treatment received irrespective of the assigned treatment.	8.6% 12/140 • Number of events 13 • 104 days The Safety Population was utilized for reporting purposes. The Safety Population includes all randomized subjects with at least 1 application of study treatment. Subjects that were randomized but did not receive application of study treatment were withdrawn from the study and therefore not included in the Safety Population. Subjects in the Safety Population were counted under the treatment received irrespective of the assigned treatment.
General disorders Pain	2.7% 4/149 • Number of events 5 • 104 days The Safety Population was utilized for reporting purposes. The Safety Population includes all randomized subjects with at least 1 application of study treatment. Subjects that were randomized but did not receive application of study treatment were withdrawn from the study and therefore not included in the Safety Population. Subjects in the Safety Population were counted under the treatment received irrespective of the assigned treatment.	5.7% 8/140 • Number of events 9 • 104 days The Safety Population was utilized for reporting purposes. The Safety Population includes all randomized subjects with at least 1 application of study treatment. Subjects that were randomized but did not receive application of study treatment were withdrawn from the study and therefore not included in the Safety Population. Subjects in the Safety Population were counted under the treatment received irrespective of the assigned treatment.

Additional Information

Director of Clinical Research

KCI | 3M

Phone: (210) 515-4060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place