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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were consented at time of surgery scheduling up to six months in advance of surgery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Control   Prevena Hip/Knee
STARTED   400 [1]   248 
COMPLETED   400   196 
NOT COMPLETED   0   52 
[1] historical control with waiver of authorization; no informed consent signed



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 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 Total of all reporting groups

Baseline Measures
   Control   Prevena Hip/Knee   Total 
Overall Participants Analyzed 
[Units: Participants]
 400   196   596 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.8  (10.8)   66.9  (10.2)   66.8  (10.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      216  54.0%      129  65.8%      345  57.9% 
Male      184  46.0%      67  34.2%      251  42.1% 


  Outcome Measures

1.  Primary:   Number of Participants With Hospital Readmissions   [ Time Frame: 60 days ]

2.  Secondary:   Number of Participants With Infection   [ Time Frame: 60 days ]

3.  Secondary:   Number of Participants With Seroma   [ Time Frame: 60 days ]

4.  Secondary:   Number of Participants With Hematoma   [ Time Frame: 60 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: karl.beer@promedica.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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