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Evaluating Advantages of Prevena After Hip and Knee Arthroplasty

Evaluating the Efficacy of the Prevena Incision Management System in Patients Undergoing Total Knee and Hip Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01854138
Enrollment
248
Registered
2013-05-15
Start date
2014-01-31
Completion date
2015-04-30
Last updated
2018-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection of Total Hip Joint Prosthesis

Keywords

primary knee arthroplasty, primary hip arthroplasty, negative pressure wound therapy

Brief summary

Determine the extent to which application of the Prevena vacuum system to clean surgical incisions immediately following surgical procedure (total hip or total knee arthroplasty) will reduce the rates of: * readmission to hospital for surgical intervention due to wound complications * seroma * hematoma * infection compared to group of patients whose wounds were covered with traditional gauze dressings.

Detailed description

The specific aim of this research project is to determine the effect of using the Prevena vacuum system on the rate of repeat surgical procedures and surgical site complications in patients having undergone a total knee or hip arthroplasty. It is believed that negative pressure wound therapy is effective in the promotion of healing of complicated, non-healing, and infected wounds in many settings. In light of this existing evidence, the investigators believe that applying negative pressure wound therapy to clean incisions, in the orthopedic setting, before infection or complication occur may prevent complications and lower overall cost of care for patients undergoing total hip or knee arthroplasty. The investigators' primary hypothesis is that application of the Prevena vacuum system to a clean incision in the operating room for patients who have undergone a total knee arthroplasty or hip replacement surgery will reduce the occurrence of repeat surgeries when the system remains in place and functional for seven days following its application. Prevena is the ideal system for this patient population because it is best suited for non-draining wounds; hip and knee arthroplasties result most often in non-draining wounds, which evidence suggests are less likely to become infected and cause other complications. Secondary hypotheses to be tested in this study are that the application and use of the Prevena vacuum system in patients who have undergone a total knee arthroplasty or hip replacement surgery will reduce the occurrence of seromas, hematomas, and will also reduce the occurrence of surgical site infections when the system remains in place and functional for seven days after application. Additionally, the investigators wish to compare the level of pain experienced by patients who use the Prevena system after surgery in comparison to those whose incision sites are covered with traditional dressings. The investigators hypothesize that patients whose wounds are dressed with the Prevena system will experience less pain than patients whose wounds are dressed with traditional dressings, which may be quite bulky and carry the risk of tape trauma injury. Finally, the investigators hypothesize that because the Prevena system will prevent surgical site complications that may lead to repeat procedures, the cost of treating patients with Prevena will be lower than the total relative cost of treating the patients whose wounds are dressed with traditional dressings.

Interventions

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.

Sponsors

ProMedica Health System
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing primary total hip or knee arthroplasty * 18-85 years of age

Exclusion criteria

* Patients undergoing revision total hip or knee arthroplasty * Allergy to silver * Current systemic infection * Currently being treated for malignancy * Patients suffering from anemia or malnutrition * Patients afflicted with jaundice * Patients deemed to be non-compliant

Design outcomes

Primary

MeasureTime frame
Number of Participants With Hospital Readmissions60 days

Secondary

MeasureTime frame
Number of Participants With Infection60 days
Number of Participants With Seroma60 days
Number of Participants With Hematoma60 days

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
Control
Retrospectively reviewed patients who underwent Total Knee or Hip Arthroplasty and received traditional gauze dressing to cover their clean surgical wound.
400
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.
196
Total596

Baseline characteristics

CharacteristicControlPrevena Hip/KneeTotal
Age, Continuous66.8 years
STANDARD_DEVIATION 10.8
66.9 years
STANDARD_DEVIATION 10.2
66.8 years
STANDARD_DEVIATION 10.6
Sex: Female, Male
Female
216 Participants129 Participants345 Participants
Sex: Female, Male
Male
184 Participants67 Participants251 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
9 / 40027 / 196
serious
Total, serious adverse events
0 / 4000 / 196

Outcome results

Primary

Number of Participants With Hospital Readmissions

Time frame: 60 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With Hospital Readmissions15 Participants
Prevena Knee/HipNumber of Participants With Hospital Readmissions3 Participants
Secondary

Number of Participants With Hematoma

Time frame: 60 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With Hematoma9 Participants
Prevena Knee/HipNumber of Participants With Hematoma0 Participants
Secondary

Number of Participants With Infection

Time frame: 60 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With Infection14 Participants
Prevena Knee/HipNumber of Participants With Infection2 Participants
Secondary

Number of Participants With Seroma

Time frame: 60 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With Seroma2 Participants
Prevena Knee/HipNumber of Participants With Seroma0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026