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Surgical WoundENABLENCT04712019

Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA

A study testing Closed Incision Negative Pressure Therapy (ciNPT) and Standard Silver-containing Dressing in people with Surgical Wound and Bilateral Total Knee Arthroplasty, run by Solventum US LLC at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty. Read more about this study

Who is it for?
Ages 22 years and older
What is being tested?
Closed Incision Negative Pressure Therapy (ciNPT) and Standard Silver-containing Dressing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
6 sitesUnited States
Study dates
6 Nov 2020to 26 Aug 2022
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 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • is at least 22 years of age on the date of informed consent.
  • can independently provide informed consent.
  • requires and is scheduled to undergo a simultaneous, bilateral, primary TKA.
  • is willing and physically capable of undergoing a simultaneous, bilateral, primary TKA with or without replacement of the patella.
  • is willing and able to return for all scheduled study visits.

Who cannot join

  • is pregnant or lactating.
  • has signs of an infection in the area of either knee or has signs of a systemic infection at the time of surgery.
  • is a chronic opioid user, defined per the CDC guidelines as opioid use for >3 months, at the time of enrollment.
  • has a current diagnosis of lymphedema in either leg.
  • has signs, symptoms, or a current diagnosis of venous insufficiency in either leg, as determined by the investigator's review of the subject's medical history.
  • has a history of clotting disorder or prior history of deep vein thrombosis
Show all 22Show fewer
  • will undergo a unilateral TKA.
  • will undergo a staged, bilateral TKA.
  • has had previous knee replacement surgery.
  • has received a corticosteroid injection into either knee within 30 days of surgery.
  • undergoes a simultaneous, bilateral TKA with a planned different incision type on each knee (eg, midline incision vs. medial parapatellar incision).
  • has known sensitivity to the study product components (drape and/or dressing materials in direct contact with the closed incision or skin).
  • has known sensitivity to silver.
  • is enrolled in another interventional clinical study.
  • has skin cancer localized at or in proximity to the incision site.
  • does not have access to an electronic device (smartphone, iPad, or computer) on a daily basis to complete online assessments.
  • has condition(s) that, in the opinion of the investigator, cause the subject to be an overall health risk that is unsuitable for the surgery.
  • has condition(s) that, in the opinion of the investigator, will impact study endpoints (eg, hemophilia or autoimmune disorders) or the ability to comply with study procedures.
  • Intra-Op Exclusion Criteria:
  • does not receive a "total" knee replacement for first knee. For example, a partial or uni-compartmental knee replacement is performed
  • has a surgical incision that would preclude placement of either dressing onto the knee
  • has a TKA resulting in a muscle flap

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Rubin Institute for Advanced Orthopedics

    Baltimore, Maryland, 21215

  • Northwell Health - Southside Hospital

    Bay Shore, New York, 11706

  • Johns Hopkins Orthopaedics

    Columbia, Maryland, 21044

  • Northwell Health - Lenox Hill Hospital

    New York, New York, 10075

  • Northwell Health - Long Island Jewish Valley Stream

    Valley Stream, New York, 11580

Other trials in United States

About this study

Official title: A Randomized Controlled Trial Evaluating Edema and ROM Using Negative Pressure Therapy Over Closed Incisions and Surrounding Soft Tissue Versus Standard Surgical Dressings in Bilateral Total Knee Arthroplasty: A Pilot Study

This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.

Being tested
Closed Incision Negative Pressure Therapy (ciNPT), Standard Silver-containing Dressing
Medical subject headings
Surgical Wound, Wounds and Injuries, Joint Diseases, Musculoskeletal Diseases, Arthralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Closed Incision Negative Pressure Therapy (ciNPT)Device

    Also called Prevena Restor ArthroForm, Prevena Plus 125 Therapy Unit

    Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision

  • Standard Silver-containing DressingDevice

    A standard silver-containing dressing applied to a closed surgical incision

Study groups in NCT04712019
Study groupRoleWhat they receive
Closed Incision Negative Pressure Therapy (ciNPT) DressingExperimentalPrevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit
Receives: Device: Closed Incision Negative Pressure Therapy (ciNPT)
Standard Silver-containing DressingActive comparatorStandard silver dressing - standard of care at hospital
Receives: Device: Standard Silver-containing Dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Lower Limb Volume

    Percent change in lower limb volume as calculated using manual circumference measurements

    Measured: 5-7 days after bilateral TKA procedure

Secondary outcomes (24)

  1. Percent Change in Lower Limb Volume

    Percent change in lower limb volume as calculated using manual circumference measurements

    Measured: 12-14 days after bilateral TKA procedure

  2. Percent Change in Lower Limb Volume

    Percent change in lower limb volume as calculated using manual circumference measurements

    Measured: 35-49 days after bilateral TKA procedure

  3. Percent Change in Lower Limb Volume

    Percent change in lower limb volume as calculated using manual circumference measurements

    Measured: 77-91 days after bilateral TKA procedure

  4. Percent Change in Lower Limb Circumference

    Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella

    Measured: 5-7 days after bilateral TKA procedure

  5. Percent Change in Lower Limb Circumference

    Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella

    Measured: 12-14 days after bilateral TKA procedure

  6. Percent Change in Lower Limb Circumference

    Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella

    Measured: 35-49 days after bilateral TKA procedure

  7. Percent Change in Lower Limb Circumference

    Percent change in circumferences measured at 10 cm above the center of the patella, at the center of patella and 10cm below the center of the patella

    Measured: 77-91 days after bilateral TKA procedure

  8. Change in Knee Flexion Angle

    Change in knee flexion angle from baseline to Visit 3

    Measured: 5-7 days after bilateral TKA procedure

  9. Change in Knee Flexion Angle

    Change in knee flexion angle from baseline to Visit 4

    Measured: 12-14 days after bilateral TKA procedure

  10. Change in Knee Flexion Angle

    Change in knee flexion angle from baseline to Visit 5

    Measured: 35-49 days after bilateral TKA procedure

  11. Change in Knee Flexion Angle

    Change in knee flexion angle from baseline to Visit 6

    Measured: 77-91 days after bilateral TKA procedure

  12. Change in Knee Extension Angle

    Change in knee extension angle from baseline to Visit 3

    Measured: 5-7 days after bilateral TKA procedure

  13. Change in Knee Extension Angle

    Change in knee extension angle from baseline to Visit 4

    Measured: 12-14 days after bilateral TKA procedure

  14. Change in Knee Extension Angle

    Change in knee extension angle from baseline to Visit 5

    Measured: 35-49 days after bilateral TKA procedure

  15. Change in Knee Extension Angle

    Change in knee extension angle from baseline to Visit 6

    Measured: 77-91 days after bilateral TKA procedure

  16. Change of Total Range of Motion in Degrees

    Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 3

    Measured: 5-7 days after bilateral TKA procedure

  17. Change of Total Range of Motion in Degrees

    Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 4

    Measured: 12-14 days after bilateral TKA procedure

  18. Change of Total Range of Motion in Degrees

    Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 5

    Measured: 35-49 days after bilateral TKA procedure

  19. Change of Total Range of Motion in Degrees

    Change of total ROM degrees, defined as the flexion angle minus the extension angle from baseline to Visit 6

    Measured: 77-91 days after bilateral TKA procedure

  20. Incidence of Surgical Site Complications (SSCs)

    Incidence of surgical site complications defined as:

    • Superficial Surgical Site Infection (SSI)
    • Deep SSI
    • Full thickness skin dehiscence
    • Seroma or hematoma requiring drainage or surgery
    • Skin necrosis
    • Continued drainage at the time of dressing removal

    Measured: within 49 days of bilateral TKA procedure

  21. Incidence of Surgical Site Complications (SSCs)

    Incidence of surgical site complications defined as:

    • Superficial Surgical Site Infection (SSI)
    • Deep SSI
    • Full thickness skin dehiscence
    • Seroma or hematoma requiring drainage or surgery
    • Skin necrosis
    • Continued drainage at the time of dressing removal

    Measured: within 91 days of bilateral TKA procedure

  22. Scar Cosmesis Assessment

    Validated tool to assess the quality of postoperative scars in clinical and research settings. Scores range from 4 (best) to 14 (worst). Due to the lack of subjects and study data, only the value recorded at the final study visit was analyzed for each subject. The average score for each study arm was then calculated with the available data.

    Measured: Long Term Follow-up occurring 77-91 days after bilateral TKA procedure

  23. Average Pain in Each Leg in the Last 24 Hours

    The average pain in each leg in the last 24 hours, using an NPRS (numerical pain rating scale) of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data.

    Measured: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure

  24. Worst Pain in Each Leg in the Last 24 Hours

    The worst pain in each leg in the last 24 hours, using an NPRS of 0-10. 0 represents No Pain with 10 representing Extremely Painful. Due to the lack of subjects and study data, only the last recorded pain value was analyzed for each subject. The average score for each study arm was then calculated with the available data.

    Measured: End of Treatment Visit occurring 12-14 days after bilateral TKA procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start6 Nov 2020
  3. Primary completion26 Aug 2022
  4. Study completion26 Aug 2022

Why it stopped: Lack of Enrollment

Resources

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
Model description
One leg receives ciNPT and the other leg receives standard silver containing dressing.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04712019
Sponsor's protocol ID
PREVENA.RESTOR.ARTHRO.2019.01
Acronym
ENABLE
Status last verified
Sep 2024
First submitted
14 Jan 2021
Last updated
1 Oct 2024
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Closed Incision Negative Pressure Therapy (ciNPT) and Standard Silver-containing Dressing in people with Surgical Wound and Bilateral Total Knee Arthroplasty, run by Solventum US LLC at 6 sites 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 5 inclusion and 22 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: stopped early, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 1 May 2024). 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?

Percent Change in Lower Limb Volume (time frame: 5-7 days after bilateral TKA procedure). 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 NCT04712019.

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 1 Oct 2024.

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