Total Knee ReplacementPhase 2NCT02118558
Negative Pressure Wound Therapy -PREVENA in Prevention of Infections After Total Knee Arthroplasty (TKA)
A Phase 2 study testing Negative Pressure Wound Therapy (NPWT) and standard prophylactic therapy in people with Total Knee Replacement, run by Hadassah Medical Organization.
Trial summary
This trial is a prospective, single center, unblinded, randomized, controlled study to assess the safety and efficacy of negative pressure wound therapy in preventing infections after TKA surgery . The study will enroll 316 patients that will undergo TKA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Negative Pressure Wound Therapy (NPWT) and standard prophylactic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages: 18 to 80
- Males- not involved in active military duty.
- Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.
Who cannot join
- Active systemic or local infection.
- History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
- Active autoimmune disease.
- Any past or present immunosuppressive treatment.
- Current treatment with chemotherapeutic agents
- History of metabolic bone disease (primary or secondary).
- Chronic renal insufficiency (defined by 50% increase of normal levels).
About this study
This trial is a prospective, single center, unblinded, randomized, controlled study to assess the safety and efficacy of negative pressure wound therapy in preventing infections after TKA surgery . The study will enroll 316 patients that will undergo TKA. patients will be randomized to the treatment group and undergo the study intervention - (NPWT) The intervention will take place at the end of the surgery. The Patients that are randomized to the control group will receive standard treatment. Both groups will be assessed at two weeks and six weeks. period.
- Conditions
- Total Knee Replacement
- Being tested
- Negative Pressure Wound Therapy (NPWT), standard prophylactic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound Therapy (NPWT)Device
standard prophylactic therapyDrug
administration of antibiotics before the first incision, keeping the surgery field sterile and performing several rinsing
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | Experimental | Not described Receives: Device: Negative Pressure Wound Therapy (NPWT) |
| standard prophylactic therapy | Active comparator | Not described Receives: Drug: standard prophylactic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks
The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks
Measured: six weeks
Secondary outcomes (2)
1. To assess the proportion on infections at two weeks and 6 weeks of follow-up.
To assess the proportion on infections at two weeks and 6 weeks of follow-up.
Measured: two weeks and six weeks
The number of patients recommended to undergo further procedural intervention because of the infection.
The number of patients recommended to undergo further procedural intervention because of the infection.
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118558
- Sponsor's protocol ID
- 0020-14-HMO-CTIL
- Status last verified
- Apr 2014
- First submitted
- 16 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy -PREVENA in Prevention of Infections After Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT02118558
- Acronym / sponsor ID
- 0020-14-HMO-CTIL
- Conditions
- Total Knee Replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a prospective, single center, unblinded, randomized, controlled study to assess the safety and efficacy of negative pressure wound therapy in preventing infections after TKA surgery . The study will enroll 316 patients that will undergo TKA. patients will be randomized to the treatment group and undergo the study intervention - (NPWT) The intervention will take place at the end of the surgery. The Patients that are randomized to the control group will receive standard treatment. Both groups will be assessed at two weeks and six weeks. period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | Experimental | Device: Negative Pressure Wound Therapy (NPWT) |
| standard prophylactic therapy | Active comparator | Drug: standard prophylactic therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages: 18 to 80
- Males- not involved in active military duty.
- Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.
Key exclusion criteria (7 listed)
- Active systemic or local infection.
- History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
- Active autoimmune disease.
- Any past or present immunosuppressive treatment.
- Current treatment with chemotherapeutic agents
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 |
|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | Device | Negative Pressure Wound Therapy (NPWT) |
| standard prophylactic therapyadministration of antibiotics before the first incision, keeping the surgery field sterile and performing several rinsing | Drug | standard prophylactic therapy |
Primary outcome
The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks
Time frame: six weeks
The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks
2 secondary outcomes
1. To assess the proportion on infections at two weeks and 6 weeks of follow-up.
Time frame: two weeks and six weeks
The number of patients recommended to undergo further procedural intervention because of the infection.
Time frame: 12 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Negative Pressure Wound Therapy (NPWT) and standard prophylactic therapy in people with Total Knee Replacement, run by Hadassah Medical Organization.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The primary endpoint of the study is to evaluate the proportion of infections at the treatment and control groups after six weeks (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2014.