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Evaluating Advantages of Prevena After Hip and Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01854138
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Karl Beer, ProMedica Health System

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infection of Total Hip Joint Prosthesis
Intervention Device: Prevena Incision Management System
Enrollment 248
Recruitment Details Patients were consented at time of surgery scheduling up to six months in advance of surgery.
Pre-assignment Details  
Arm/Group Title Control Prevena Hip/Knee
Hide Arm/Group Description Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.

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.

Period Title: Overall Study
Started 400 [1] 248
Completed 400 196
Not Completed 0 52
[1]
historical control with waiver of authorization; no informed consent signed
Arm/Group Title Control Prevena Hip/Knee Total
Hide Arm/Group Description Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.

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 of all reporting groups
Overall Number of Baseline Participants 400 196 596
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 400 participants 196 participants 596 participants
66.8  (10.8) 66.9  (10.2) 66.8  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 400 participants 196 participants 596 participants
Female
216
  54.0%
129
  65.8%
345
  57.9%
Male
184
  46.0%
67
  34.2%
251
  42.1%
1.Primary Outcome
Title Number of Participants With Hospital Readmissions
Hide Description [Not Specified]
Time Frame 60 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Prevena Knee/Hip
Hide Arm/Group Description:
Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.

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.

Overall Number of Participants Analyzed 400 196
Measure Type: Count of Participants
Unit of Measure: Participants
15
   3.8%
3
   1.5%
2.Secondary Outcome
Title Number of Participants With Infection
Hide Description [Not Specified]
Time Frame 60 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Prevena Hip/Knee
Hide Arm/Group Description:
Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.

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 Number of Participants Analyzed 400 196
Measure Type: Count of Participants
Unit of Measure: Participants
14
   3.5%
2
   1.0%
3.Secondary Outcome
Title Number of Participants With Seroma
Hide Description [Not Specified]
Time Frame 60 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Prevena Hip/Knee
Hide Arm/Group Description:
Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.

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 Number of Participants Analyzed 400 196
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.5%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With Hematoma
Hide Description [Not Specified]
Time Frame 60 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Prevena Hip/Knee
Hide Arm/Group Description:
Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.

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 Number of Participants Analyzed 400 196
Measure Type: Count of Participants
Unit of Measure: Participants
9
   2.3%
0
   0.0%
Time Frame 6 weeks postoperatively
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Prevena Hip/Knee
Hide Arm/Group Description Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.

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.

All-Cause Mortality
Control Prevena Hip/Knee
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control Prevena Hip/Knee
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/400 (0.00%)      0/196 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Prevena Hip/Knee
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/400 (2.25%)      27/196 (13.78%)    
Skin and subcutaneous tissue disorders     
Other reactions *  9/400 (2.25%)  9 27/196 (13.78%)  27
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Karl J. Beer, MD
Organization: ProMedica
Phone: 419-578-4260
Responsible Party: Karl Beer, ProMedica Health System
ClinicalTrials.gov Identifier: NCT01854138     History of Changes
Other Study ID Numbers: KCI-1333
IRB#13-033 ( Other Identifier: ProMedica Institutional Review Board )
First Submitted: May 12, 2013
First Posted: May 15, 2013
Results First Submitted: April 4, 2018
Results First Posted: July 12, 2018
Last Update Posted: July 12, 2018