A Study to Assess the Prevention of Postsurgical Incision Healing Complications in Patients Undergoing Primary or Revision Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA), Treated With Either Single-Use Negative Pressure Wound Therapy (NPWT) or Standard Postsurgical Dressings.



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2014

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A Prospective, Randomized, Controlled Clinical Study to Assess the Prevention of Postsurgical Incision Healing Complications in Patients Undergoing Primary or Revision Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA), Treated With Either Single-Use Negative Pressure Wound Therapy (NPWT) or Standard Postsurgical Dressings.

The aim of this study is to assess the prevention of incision healing complications in
patients undergoing TKA and THA treated with either Single-Use Incisional NPWT (Negative
Pressure Wound Therapy), or standard of care dressings.


Inclusion Criteria:

1. - Patient ≥18 years old

2. - Male or non-pregnant females

3. - Patient is scheduled to have a surgical procedure for Total Knee Arthroplasty or
Total Hip Arthroplasty (Primary or Revision Procedure)

4. - The patient is able to understand the trial and is willing to consent to the trial

Exclusion Criteria:

1. - Patients who in the opinion of the investigator may not complete the study for any
reason

2. - Patients with a known history of poor compliance with medical treatment

3. - Patients who have participated in this trial previously and who were withdrawn

4. - Patients with known allergies to product components (silicone adhesives and
polyurethane films (direct contact with wound), acrylic adhesives (direct contact
with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within
the dressing)

5. - Patients not capable of obtaining a standardized digital picture at day 7 (1 week
from surgery), and submitting it to the site.
We found this trial at
1
site
Columbia, Missouri 65212
Phone: 573-882-7189
?
mi
from
Columbia, MO
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