Linear or Emi-linear IncisionsPhase 4Prevena2009-45NCT01380665
Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty
A Phase 4 study testing Prevena Incisional Management System in people with Linear or Emi-linear Incisions and Total Hip Arthroplasty, run by KCI USA, Inc.
Trial summary
The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Linear or Emi-linear Incisions, Total Hip Arthroplasty, Total Knee Arthroplasty
- What is being tested?
- Prevena Incisional Management System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be ≥ 18 years of age
- Subject must, at the treating physician's determination and definition, be an appropriate Candidate for primary total hip or knee arthroplasty
- Subjects who undergo primary total knee or hip arthroplasty must have a linear or semi-linear incision whose length and curvature should fit within the dimensions bound by the polyurethane foam (10 inches in length by 2.5 inches in width)
- Subject is able and willing to provide written informed consent and comply with visit schedule
- Subject must agree to avoid application of tanning lotions or exposure of ultraviolet radiation from sun or artificial sources such as a tanning bed on operative area for the duration of study participation
- Subject must not be pregnant if of child-bearing potential, or otherwise must be surgically sterilized or unable to conceive. All females, regardless of child-bearing potential, will receive a urine hCG test 2 weeks prior to surgery and the test result must be negative for pregnancy.
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- Subjects who are of child-bearing potential must be utilizing an acceptable method of birth control (eg, birth control pills, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc) and be willing to continue birth control for duration of study participation. If birth control method is the form of birth control pills, shots, implants skin patches, or IUD, the method must have been utilized for at least 30 days prior to study participation.
- Subject must be willing to wear loose fitting clothing for duration of treatment period
- Subject must be willing to comply with visit schedule for the duration of the study
Who cannot join
- Positive pregnancy test confirmed by hCG in urine
- Current or past (30 days prior to surgery) within time of screening attempts to become pregnant
- Current local or systemic infection (eg, skin infections, sinus infections, urinary tract infection, sepsis, etc)
- Current or past (14 days prior to surgery) within time of screening topical treatments on operative area (eg, laser hair or tattoo removal, sunless tanning lotions)
- Current or past (14 days prior to surgery) steroid topical therapies on operative area
- Current or past (30 days prior to surgery) use of oral steroids (NOTE: Use of non-topical, ophthalmic or aerosol types of steroids (ie, inhaled corticosteroids) are permitted at screening and throughout the clinical trial)
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- Current or past (72 hours prior to surgery) within surgery use of antihistamines
- Current or past (30 days prior to surgery) within time of screening use of oral Tetracycline or AcutaneTM or topical Tetracycline or AcutaneTM on the operative area
- Presence of skin lesions or abnormalities on operative area
- Current or past malignancy requiring immunosuppressant therapy or chemotherapy within 5 years within time of screening
- Presence of excessive skin folds on operative area
- Intentional exposure of the operative area to ultraviolet radiation (14 days prior to surgery) within time of screening (ie, sunbathing or tanning bed)
- Presence of sunburned or peeling skin on operative area
- Tattoos on operative area
- Presence of severe, raised scar tissue on operative area which may interfere with pre and post skin evaluation assessments
- Presence of an open wound prior to the index surgical procedure on operative area
- Reported alcohol (≥ 3 drinks per day) or drug abuse within the past 6 months
- Topical hypersensitivity or allergy to any disposable components of the dressing system (eg, silver, polyurethane, polyester, or acrylic adhesive)
- Topical hypersensitivity or allergy towards any medical adhesive
- Current enrollment or past participation in this clinical study or any other study within ≤30 days
- Any systemic or local active dermatological disease that might interfere with the evaluation of the operative area (eg, Meleney's ulcer, scleroderma, chronic urticaria, psoriasis, skin cancer, eczema, seborrhea, or malignancy)
- Connective tissue disease or collagen vascular disease (eg, Ehlers-Danlos syndrome, systemic lupus erythematosus, rheumatoid arthritis)
- Current or history of hematological disorders or conditions (eg, polycythemia vera, thrombocythemia, sickle-cell disease)
- Any Subject with conditions which can potentially result in abnormally pigmented skin (eg, melasma, vitiligo, pityriasis versicolor)
- Inability or refusal to wear loose fitting clothing for the duration of the treatment period
- Subjects in whom orthopaedic reconstruction is required in addition to total hip or knee arthroplasty
- Subjects who are having the total hip or knee arthroplasty as a result of acute orthopaedic trauma
- Subjects who have incurred acute orthopaedic trauma (ie, hip fracture) recently or at any time
- Subjects who have either acute or chronic open/active wounds present (including biopsies, ulcerations, etc)
- Subjects in whom the index procedure is a revision of a total hip or knee arthroplasty
- Subjects in whom the primary or partial total hip or knee arthroplasty would also be performed on the contra lateral knee or hip at the same time
About this study
Official title: Prospective, Single Arm, Post-Marketing Trial to Examine the Safety and Functionality of the Prevena™ Incision Management System, A Negative Pressure Based Surgical Wound Management System, Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty
The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.
- Being tested
- Prevena Incisional Management System
- Keywords
- Prevena, Incision, Management, System, total, knee, hip, replacement, Surgery, Negative, Pressure, dressing, KCI
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena Incisional Management SystemDevice
All evaluable patients will utilize the Prevena Incisional Management System
| Study group | Role | What they receive |
|---|---|---|
| There is one group of 100 patients | Other | 50 of these patients will receive a total hip replacement; 50 patients will receive a total knee replacement; Receives: Device: Prevena Incisional Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative pressure environment with accurate and reliable indicators;Dressing biocompatible with incision site and skin;Minimal dressing changes during therapy;Acceptable safety profile; minimal/no AEs;Patient comfort and dressing integrity after surgery
Measured: during hospitalization (up to 7 days) and thru follow-up 30 days after dressing removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Linear or Emi-linear IncisionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380665
- Sponsor's protocol ID
- Prevena2009-45
- Acronym
- Prevena2009-45
- Status last verified
- Oct 2024
- First submitted
- 9 Jun 2011
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Post-Marketing Trial to Examine the Safety and Functionality of the Prevena™ Incision Management System, A Negative Pressure Based Surgical Wound Management System, Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01380665
- Acronym / sponsor ID
- Prevena2009-45 / Prevena2009-45
- Keywords
- Prevena, Incision, Management, System, total, knee, hip, replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Jun 2011 (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.
The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| There is one group of 100 patients | Other | Device: Prevena Incisional Management System50 of these patients will receive a total hip replacement; 50 patients will receive a total knee replacement; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must be ≥ 18 years of age
- Subject must, at the treating physician's determination and definition, be an appropriate Candidate for primary total hip or knee arthroplasty
- Subjects who undergo primary total knee or hip arthroplasty must have a linear or semi-linear incision whose length and curvature should fit within the dimensions bound by the polyurethane foam (10 inches in length by 2.5 inches in width)
- Subject is able and willing to provide written informed consent and comply with visit schedule
- Subject must agree to avoid application of tanning lotions or exposure of ultraviolet radiation from sun or artificial sources such as a tanning bed on operative area for the duration of study participation
Key exclusion criteria (31 listed)
- Positive pregnancy test confirmed by hCG in urine
- Current or past (30 days prior to surgery) within time of screening attempts to become pregnant
- Current local or systemic infection (eg, skin infections, sinus infections, urinary tract infection, sepsis, etc)
- Current or past (14 days prior to surgery) within time of screening topical treatments on operative area (eg, laser hair or tattoo removal, sunless tanning lotions)
- Current or past (14 days prior to surgery) steroid topical therapies on operative area
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 |
|---|---|---|
| Prevena Incisional Management SystemAll evaluable patients will utilize the Prevena Incisional Management System | Device | There is one group of 100 patients |
Primary outcome
Negative pressure environment with accurate and reliable indicators;Dressing biocompatible with incision site and skin;Minimal dressing changes during therapy;Acceptable safety profile; minimal/no AEs;Patient comfort and dressing integrity after surgery
Time frame: during hospitalization (up to 7 days) and thru follow-up 30 days after dressing removal
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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 4 study testing Prevena Incisional Management System in people with Linear or Emi-linear Incisions and Total Hip Arthroplasty, run by KCI USA, Inc.
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 9 inclusion and 31 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: withdrawn, as of the sponsor's last update on 16 Oct 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Negative pressure environment with accurate and reliable indicators;Dressing biocompatible with incision site and skin;Minimal dressing changes during therapy;Acceptable safety profile; minimal/no AEs;Patient comfort and dressing integrity after surgery (time frame: during hospitalization (up to 7 days) and thru follow-up 30 days after dressing removal). 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 16 Oct 2024.