CompletedNot Applicable

Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty

United States294 participantsStarted 2017-12-05

Plain-language summary

This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care dressing.

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

✓. a one-stage aseptic revision procedure
✓. a one-stage septic exchange procedure (requiring removal of all hardware) for acute postoperative infection
✓. removal of cement spacer and re-implantation procedure
✓. open reduction and internal fixation of peri-prosthetic fractures
✓. a body mass index (BMI) greater than 35 kg/m2
✓. a requirement for the use of blood thinners other than acetylsalicylic acid (ASA) after surgery
✓. history of or current peripheral vascular disease
✓. the presence of lymphedema in the operative limb

What they're measuring

Number of Participants With Surgical Site Complications (SSC)

Timeframe: within 90 days after TKA revision

Trial details

NCT IDNCT03274466

SponsorKCI USA, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-27

Results submitted2020-11-11

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