Trial Outcomes & Findings for Evaluating Advantages of Prevena After Hip and Knee Arthroplasty (NCT NCT01854138)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

248 participants

Primary outcome timeframe

60 days

Results posted on

2018-07-12

Participant Flow

Patients were consented at time of surgery scheduling up to six months in advance of surgery.

Participant milestones

Participant milestones
Measure	Control Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.	Prevena Hip/Knee Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasy and receiving Prevena Incision Management System on the clean surgical wound. Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days. Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.
Overall Study STARTED	400	248
Overall Study COMPLETED	400	196
Overall Study NOT COMPLETED	0	52

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Advantages of Prevena After Hip and Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=400 Participants Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.	Prevena Hip/Knee n=196 Participants Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound. Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days. Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.	Total n=596 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 10.8 • n=5 Participants	66.9 years STANDARD_DEVIATION 10.2 • n=7 Participants	66.8 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	216 Participants n=5 Participants	129 Participants n=7 Participants	345 Participants n=5 Participants
Sex: Female, Male Male	184 Participants n=5 Participants	67 Participants n=7 Participants	251 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

Outcome measures

Outcome measures
Measure	Control n=400 Participants Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.	Prevena Knee/Hip n=196 Participants Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound. Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.
Number of Participants With Hospital Readmissions	15 Participants	3 Participants

SECONDARY outcome

Timeframe: 60 days

Outcome measures

Outcome measures
Measure	Control n=400 Participants Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.	Prevena Knee/Hip n=196 Participants Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound. Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.
Number of Participants With Infection	14 Participants	2 Participants

SECONDARY outcome

Timeframe: 60 days

Outcome measures

Outcome measures
Measure	Control n=400 Participants Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.	Prevena Knee/Hip n=196 Participants Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound. Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.
Number of Participants With Seroma	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 days

Outcome measures

Outcome measures
Measure	Control n=400 Participants Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.	Prevena Knee/Hip n=196 Participants Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty and receiving Prevena Incision Management System on the clean surgical wound. Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.
Number of Participants With Hematoma	9 Participants	0 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Prevena Hip/Knee

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=400 participants at risk Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.	Prevena Hip/Knee n=196 participants at risk Prospectively enrolled patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasy and receiving Prevena Incision Management System on the clean surgical wound. Prevena Incision Management System: Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days. Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.
Skin and subcutaneous tissue disorders Other reactions	2.2% 9/400 • Number of events 9 • 6 weeks postoperatively	13.8% 27/196 • Number of events 27 • 6 weeks postoperatively

Additional Information

Karl J. Beer, MD

ProMedica

Phone: 419-578-4260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place