Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressi⦠(NCT04712019) | Clinical Trial Compass
TerminatedNot Applicable
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
Stopped: Lack of Enrollment
United States10 participantsStarted 2020-11-06
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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 sensitivā¦