Prosthesis-related InfectionsNCT02127281
Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.
A study testing Prevena in people with Prosthesis-related Infections and Wound Complications, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of a negative pressure wound therapy (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis-related Infections, Wound Complications, Joint Diseases
- What is being tested?
- Prevena
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled revision Total Hip or Knee Arthroplasty Procedure
- Presence of one of the following: body mass index (BMI) greater than 35, use of blood thinners other than acetylsalicylic acid (ASA) after surgery, peripheral vascular disease, depression, diabetes mellitus, current tobacco use, history of prior infection, current use of immunomodulators or steroids, current history of cancer or hematological malignancy, rheumatoid arthritis, renal failure or dialysis, malnutrition, liver disease, transplant status, or HIV.
Who cannot join
- Patient lives >100 miles from hospital
- Patient is < 18 years old
- Silver allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Knee and Hip Revision Arthroplasty.
The purpose of this study is to determine the efficacy of a negative pressure wound therapy (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for infection. It is hypothesized that the use of NPWT system (i.e., Prevena) in high risk patients prevents wound complications and decreases reoperation rates.
Read the detailed description
One of the primary causes of un-planned readmission following lower extremity arthroplasty procedures is infection. Continuous wound drainage poses a serious risk for infection and is often initially treated with absorbent dressings and/or oral antibiotics. Comorbidities such as obesity, diabetes and tobacco abuse predisposes to wound complications and therefore infection after these procedures. NPWT has proven to be effective for postoperative drainage and decreases the risk for infection or further reoperation. This prospective randomized trial will involve 160 patients at high risk for infection undergoing revision total knee or hip arthroplasty; 80 patients will be randomly selected to be treated with the NPWT system (Prevena) and randomly selected to be treated with the current standard of care wound dressing (control group). Patients will be enrolled at a single site of the Cleveland Clinic Health System (Main Campus).
- Conditions
- Prosthesis-related Infections, Wound Complications, Joint Diseases, Musculoskeletal Diseases
- Being tested
- Prevena
- Keywords
- Revision total knee arthroplasty, Revision total hip arthroplasty, Negative pressure wound therapy system (NPWT), Drainage
- Medical subject headings
- Prosthesis-Related Infections, Joint Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevenaDevice
Device will be applied at end of procedure over closed incision.
| Study group | Role | What they receive |
|---|---|---|
| Prevena | Active comparator | Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Receives: Device: Prevena |
| Control | No intervention | A standard of care sterile wound dressing will be placed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Wound Complications
Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.
Measured: Within 90 days after surgery
Re-operation Rates
Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision
Measured: Within 90 days after surgery
Readmission Rates
Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision
Measured: Within 90 days after surgery
Secondary outcomes (7)
Knee Flexion
Mean knee flexion (degrees) at 4 weeks postoperatively
Measured: 4 weeks postoperative
HOOS and KOOS Scores at 90 Days Postoperatively
Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score.
Measured: 90 days postoperative
Timed-up-and-go Test
Median Timed-up-and-go test (seconds)
Measured: 4 weeks postoperatively
Hip Range of Motion (Flexion)
Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively
Measured: 4 weeks postoperative
VR-12 Questionnaire
Mean VR-12 scores, presented as 2 composite scores physical component summary (PCS) and mental component summary (MCS). Physical Component Score (PCS): Provides greater emphasis on questions about general health, physical functioning and role playing and bodily pain. Mental Component Score (MCS): Provides greater emphasis on questions about role-emotional, vitality/mental health and social functioning. PCS and MCS summary scores are standardized using a z-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10. Higher MCS and PCS scores reflect better overall physical and mental health, respectively.
Measured: 90 days postoperatively
Hip Range of Motion
Median hip range of motion (extension, in degrees) at 4 weeks postoperatively
Measured: 4 weeks postoperative
Knee Extension
Median knee extension (degrees) at 4 weeks postoperatively
Measured: 4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completion24 Apr 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prosthesis-related InfectionsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- KCI USA, Inc
- Responsible party
- Principal investigator, Carlos Higuera-Rueda, The Cleveland Clinic
- Investigators
- Carlos Higuera-Rueda, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127281
- Sponsor's protocol ID
- CCF 14-273
- Status last verified
- Aug 2018
- First submitted
- 29 Apr 2014
- Last updated
- 19 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hansen E, Durinka JB, Costanzo JA, Austin MS, Deirmengian GK. Negative pressure wound therapy is associated with resolution of incisional drainage in most wounds after hip arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3230-6. doi: 10.1007/s11999-013-2937-3.
PubMed 23539123Bozic KJ, Kurtz SM, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res. 2010 Jan;468(1):45-51. doi: 10.1007/s11999-009-0945-0. Epub 2009 Jun 25.
PubMed 19554385
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Knee and Hip Revision Arthroplasty.
- ClinicalTrials.gov ID
- NCT02127281
- Acronym / sponsor ID
- CCF 14-273
- Conditions
- Prosthesis-related Infections, Wound Complications, Joint Diseases, Musculoskeletal Diseases
- Keywords
- Revision total knee arthroplasty, Revision total hip arthroplasty, Negative pressure wound therapy system (NPWT), Drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- KCI USA, Inc
- Study start
- May 2014
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Posted 26 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of a negative pressure wound therapy (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for infection. It is hypothesized that the use of NPWT system (i.e., Prevena) in high risk patients prevents wound complications and decreases reoperation rates.
Detailed description
One of the primary causes of un-planned readmission following lower extremity arthroplasty procedures is infection. Continuous wound drainage poses a serious risk for infection and is often initially treated with absorbent dressings and/or oral antibiotics. Comorbidities such as obesity, diabetes and tobacco abuse predisposes to wound complications and therefore infection after these procedures. NPWT has proven to be effective for postoperative drainage and decreases the risk for infection or further reoperation. This prospective randomized trial will involve 160 patients at high risk for infection undergoing revision total knee or hip arthroplasty; 80 patients will be randomly selected to be treated with the NPWT system (Prevena) and randomly selected to be treated with the current standard of care wound dressing (control group). Patients will be enrolled at a single site of the Cleveland Clinic Health System (Main Campus).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevena | Active comparator | Device: PrevenaPrevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). |
| Control | No intervention | –A standard of care sterile wound dressing will be placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled revision Total Hip or Knee Arthroplasty Procedure
- Presence of one of the following: body mass index (BMI) greater than 35, use of blood thinners other than acetylsalicylic acid (ASA) after surgery, peripheral vascular disease, depression, diabetes mellitus, current tobacco use, history of prior infection, current use of immunomodulators or steroids, current history of cancer or hematological malignancy, rheumatoid arthritis, renal failure or dialysis, malnutrition, liver disease, transplant status, or HIV.
Key exclusion criteria (3 listed)
- Patient lives >100 miles from hospital
- Patient is < 18 years old
- Silver allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrevenaDevice will be applied at end of procedure over closed incision. | Device | Prevena |
Primary outcome
Number of Patients With Wound Complications
Time frame: Within 90 days after surgery
Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.
Re-operation Rates
Time frame: Within 90 days after surgery
Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision
Readmission Rates
Time frame: Within 90 days after surgery
Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision
7 secondary outcomes
Knee Flexion
Time frame: 4 weeks postoperative
HOOS and KOOS Scores at 90 Days Postoperatively
Time frame: 90 days postoperative
Timed-up-and-go Test
Time frame: 4 weeks postoperatively
Hip Range of Motion (Flexion)
Time frame: 4 weeks postoperative
VR-12 Questionnaire
Time frame: 90 days postoperatively
Hip Range of Motion
Time frame: 4 weeks postoperative
Knee Extension
Time frame: 4 weeks postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23539123Hansen E, Durinka JB, Costanzo JA, Austin MS, Deirmengian GK. Negative pressure wound therapy is associated with resolution of incisional drainage in most wounds after hip arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3230-6. doi: 10.1007/s11999-013-2937-3.
- Background: PubMed 19554385Bozic KJ, Kurtz SM, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res. 2010 Jan;468(1):45-51. doi: 10.1007/s11999-009-0945-0. Epub 2009 Jun 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Higuera-Rueda, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena in people with Prosthesis-related Infections and Wound Complications, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Wound Complications (time frame: Within 90 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127281, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.