Wound SurgicalNCT07770633
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
A study testing NP Seal, PICO and Prevena in people with Wound Surgical and Diabetes, run by The Cleveland Clinic.
Trial summary
This study is a single-center, prospective, randomized, open-label clinical trial evaluating three commercially available closed-incision negative pressure wound therapy (ciNPWT) devices: NPseal, PICO, and Prevena, in adult patients undergoing primary total knee arthroplasty (TKA) who meet predefined high-risk… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Surgical, Diabetes, Obesity
- What is being tested?
- NP Seal, PICO and Prevena
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Undergoing primary total knee arthroplasty
- Able to understand the study, provide informed consent, and participate in study procedures
- Meet at least one of the following co-morbidities:
- BMI ≥35
- Diabetes
- Prior surgical incision(s) in the operative area
- Chronic kidney disease
Who cannot join
- Prisoners
- Pregnant women
- Patients who indicate they may not comply with post-operative instructions
- Patients with active bleeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Clinical Trial for Closed Incision Negative Pressure Wound Therapy (NPWT) Devices in Total Knee Arthroplasty (TKA)
This study is a single-center, prospective, randomized, open-label clinical trial evaluating three commercially available closed-incision negative pressure wound therapy (ciNPWT) devices: NPseal, PICO, and Prevena, in adult patients undergoing primary total knee arthroplasty (TKA) who meet predefined high-risk criteria for wound complications.
A total of approximately 300 participants will be enrolled and randomized in a 1:1:1 fashion to receive one of the three study dressings applied over the closed surgical incision at the end of the procedure. All participants will otherwise receive standard perioperative and postoperative care. The primary follow-up period will extend through 90 days after surgery.
Read more
The primary objective is to compare the incidence of 90-day surgical site complications, including superficial infection, wound dehiscence, seroma, and hematoma, across the three dressing groups. Secondary objectives include evaluation of device usability, patient experience, and device-related issues (such as loss of seal, alarms, tubing or pump problems, fluid saturation, and premature dressing changes), as well as assessment of the interaction between skin closure method and device performance.
Research-specific activities are limited to eligibility confirmation, informed consent, randomization, administration of a brief postoperative patient survey at approximately postoperative day 7 and/or dressing removal, provider assessment of the dressing at removal, and collection of clinical outcomes from the medical record. No additional blood draws, imaging, or invasive procedures are required for participation.
This study is designed to address a gap in the literature by providing head-to-head comparative data on commonly used ciNPWT systems in a high-risk primary TKA population, with the goal of informing postoperative wound management strategies in clinical practice.
- Conditions
- Wound Surgical, Diabetes, Obesity, Chronic Kidney Diseases, Smoking
- Being tested
- NP Seal, PICO, Prevena
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement
- Medical subject headings
- Surgical Wound, Diabetes Mellitus, Obesity, Renal Insufficiency, Chronic, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP SealDevice
Designed to maintain negative pressure without an external battery-powered pump or canister.
PICODevice
Designed to deliver negative pressure for up to 7 days and has visual alerts for issues such as air leaks, low battery, or dressing change
PrevenaDevice
Designed to deliver continuous negative pressure over the closed incision and collect fluid in a separate canister.
| Study group | Role | What they receive |
|---|---|---|
| NP Seal | Active comparator | NP Seal is a single-use negative pressure dressing with an integrated mechanical pinch pump. It is applied over the closed incision. Receives: Device: NP Seal |
| PICO dressing | Active comparator | PICO is a single-use negative pressure dressing connected to a small portable pump. Receives: Device: PICO |
| Prevena dressing | Active comparator | Prevena is a closed-incision negative pressure dressing connected to a portable therapy unit. Receives: Device: Prevena |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complications
Incidence of 90-day surgical site complications among patients receiving NPseal, PICO, or Prevena dressings.
Measured: From day of surgery to 90days post-op
Secondary outcomes (2)
Patient Post-Operative Dressing Survey
Patient-reported experience to evaluate device usability, satisfaction, and device-related issues (including adequacy of instructions, maintenance of seal/suction, device alarms or warnings, tubing or pump disconnections, fluid saturation, need for early dressing replacement, ease of use, provider communication regarding device benefits, and willingness to use the dressing again).
Measured: From day of surgery to 90days post-op
Provider Assessment Survey
Clinical evaluation of the skin closure technique and the compatibility of device performance on wound healing
Measured: From day of surgery to 90days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start9 Nov 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound SurgicalStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments
- Responsible party
- Principal investigator, Nicolas Piuzzi, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770633
- Sponsor's protocol ID
- 26-462
- Status last verified
- Nov 2026
- First submitted
- 7 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial for Closed Incision Negative Pressure Wound Therapy (NPWT) Devices in Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT07770633
- Acronym / sponsor ID
- 26-462
- Conditions
- Wound Surgical, Diabetes, Obesity, Chronic Kidney Diseases, Smoking
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Stryker Instruments
- Study start
- 9 Nov 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Aug 2026 (actual)
- 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 study is a single-center, prospective, randomized, open-label clinical trial evaluating three commercially available closed-incision negative pressure wound therapy (ciNPWT) devices: NPseal, PICO, and Prevena, in adult patients undergoing primary total knee arthroplasty (TKA) who meet predefined high-risk criteria for wound complications.
A total of approximately 300 participants will be enrolled and randomized in a 1:1:1 fashion to receive one of the three study dressings applied over the closed surgical incision at the end of the procedure. All participants will otherwise receive standard perioperative and postoperative care. The primary follow-up period will extend through 90 days after surgery.
The primary objective is to compare the incidence of 90-day surgical site complications, including superficial infection, wound dehiscence, seroma, and hematoma, across the three dressing groups. Secondary objectives include evaluation of device usability, patient experience, and device-related issues (such as loss of seal, alarms, tubing or pump problems, fluid saturation, and premature dressing changes), as well as assessment of the interaction between skin closure method and device performance.
Research-specific activities are limited to eligibility confirmation, informed consent, randomization, administration of a brief postoperative patient survey at approximately postoperative day 7 and/or dressing removal, provider assessment of the dressing at removal, and collection of clinical outcomes from the medical record. No additional blood draws, imaging, or invasive procedures are required for participation.
This study is designed to address a gap in the literature by providing head-to-head comparative data on commonly used ciNPWT systems in a high-risk primary TKA population, with the goal of informing postoperative wound management strategies in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NP Seal | Active comparator | Device: NP SealNP Seal is a single-use negative pressure dressing with an integrated mechanical pinch pump. It is applied over the closed incision. |
| PICO dressing | Active comparator | Device: PICOPICO is a single-use negative pressure dressing connected to a small portable pump. |
| Prevena dressing | Active comparator | Device: PrevenaPrevena is a closed-incision negative pressure dressing connected to a portable therapy unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Undergoing primary total knee arthroplasty
- Able to understand the study, provide informed consent, and participate in study procedures
- BMI ≥35
- Diabetes
Key exclusion criteria (4 listed)
- Prisoners
- Pregnant women
- Patients who indicate they may not comply with post-operative instructions
- Patients with active bleeding
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 |
|---|---|---|
| NP SealDesigned to maintain negative pressure without an external battery-powered pump or canister. | Device | NP Seal |
| PICODesigned to deliver negative pressure for up to 7 days and has visual alerts for issues such as air leaks, low battery, or dressing change | Device | PICO dressing |
| PrevenaDesigned to deliver continuous negative pressure over the closed incision and collect fluid in a separate canister. | Device | Prevena dressing |
Primary outcome
Surgical complications
Time frame: From day of surgery to 90days post-op
Incidence of 90-day surgical site complications among patients receiving NPseal, PICO, or Prevena dressings.
2 secondary outcomes
Patient Post-Operative Dressing Survey
Time frame: From day of surgery to 90days post-op
Provider Assessment Survey
Time frame: From day of surgery to 90days post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing NP Seal, PICO and Prevena in people with Wound Surgical and Diabetes, run by The Cleveland Clinic.
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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Piuzzi, MD (216-445-9109, piuzzin@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical complications (time frame: From day of surgery to 90days post-op). 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 4 Nov 2026.