Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
KCI USA, Inc
With
3M
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The subject:
is at least 22 years of age on the date of informed consent
is able to provide their own informed consent
requires a TKA revision defined as one of the following:
1. a one-stage aseptic revision procedure
2. a one-stage septic exchange procedure (requiring removal of all hardware) for acute postoperative infection
3. removal of cement spacer and re-implantation procedure
4. open reduction and internal fixation of peri-prosthetic fractures
has one or more of the following:
1. a body mass index (BMI) greater than 35 kg/m2
2. a requirement for the use of blood thinners other than acetylsalicylic acid (ASA) after surgery
3. history of or current peripheral vascular disease
4. the presence of lymphedema in the operative limb
5. insulin-dependent diabetes mellitus
6. current tobacco use or previous history of smoking and quitting within the past 30 days
7. a history of prior infection of the operative site
8. current use of immunomodulators or steroids
9. current or history of cancer or hematological malignancy (excluding localized skin cancer)
10. rheumatoid arthritis
11. current renal failure or dialysis
12. malnutrition as determined by the investigator
13. liver disease as determined by the investigator
14. status post solid organ transplant
15. HIV
is willing and able to return for all scheduled study visits
if female, has a negative urine or serum pregnancy test at screening and day of revision surgery. Women who have had surgical sterilization by a medically accepted method such as tubal ligation, hysterectomy, or oophorectomy or are post-menopausal, defined as not having menstruation for \>= 12 months will be excluded from requiring this test.
The subject:
has undergone a TKA revision resulting in a closed surgical incision
You may not be if
The subject:
is pregnant or lactating
will undergo a bilateral TKA within the same operative visit
will undergo a bilateral TKA in which the first TKA surgery is on the knee selected for study
will undergo a staged bilateral TKA in which the TKA revision surgery for the knee under study occurs within 30 days of the first TKA procedure
was previously randomized in this protocol
has a systemic active infection at the time of revision not including chronic viral infections such as HIV or hepatitis
has a remote-site skin infection at the time of revision
was tattooed on the area of the incision within 30 days prior to randomization
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 currently enrolled in another investigational trial that requires additional interventions
is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study
has localized skin cancer around the incision site
The subject:
has a surgical incision that precludes placement of dressing
has a TKA revision resulting in a muscle flap
has a TKA revision resulting in the placement of a spacer
has an incision drainage and debridement procedure only
