| Eligibility |
Inclusion Criteria:
1. Subject must be = 18 years of age
2. Subject must, at the treating physician's determination and definition, be an
appropriate Candidate for primary total hip or knee arthroplasty
3. Subjects who undergo primary total knee or hip arthroplasty must have a linear or
semi-linear incision whose length and curvature should fit within the dimensions bound
by the polyurethane foam (10 inches in length by 2.5 inches in width)
4. Subject is able and willing to provide written informed consent and comply with visit
schedule
5. Subject must agree to avoid application of tanning lotions or exposure of ultraviolet
radiation from sun or artificial sources such as a tanning bed on operative area for
the duration of study participation
6. Subject must not be pregnant if of child-bearing potential, or otherwise must be
surgically sterilized or unable to conceive. All females, regardless of child-bearing
potential, will receive a urine hCG test 2 weeks prior to surgery and the test result
must be negative for pregnancy.
7. Subjects who are of child-bearing potential must be utilizing an acceptable method of
birth control (eg, birth control pills, condom with spermicide, diaphragm with
spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc) and be
willing to continue birth control for duration of study participation. If birth
control method is the form of birth control pills, shots, implants skin patches, or
IUD, the method must have been utilized for at least 30 days prior to study
participation.
8. Subject must be willing to wear loose fitting clothing for duration of treatment
period
9. Subject must be willing to comply with visit schedule for the duration of the study
Exclusion Criteria:
1. Positive pregnancy test confirmed by hCG in urine
2. Current or past (30 days prior to surgery) within time of screening attempts to become
pregnant
3. Current local or systemic infection (eg, skin infections, sinus infections, urinary
tract infection, sepsis, etc)
4. Current or past (14 days prior to surgery) within time of screening topical treatments
on operative area (eg, laser hair or tattoo removal, sunless tanning lotions)
5. Current or past (14 days prior to surgery) steroid topical therapies on operative area
6. Current or past (30 days prior to surgery) use of oral steroids (NOTE: Use of
non-topical, ophthalmic or aerosol types of steroids (ie, inhaled corticosteroids) are
permitted at screening and throughout the clinical trial)
7. Current or past (72 hours prior to surgery) within surgery use of antihistamines
8. Current or past (30 days prior to surgery) within time of screening use of oral
Tetracycline or AcutaneTM or topical Tetracycline or AcutaneTM on the operative area
9. Presence of skin lesions or abnormalities on operative area
10. Current or past malignancy requiring immunosuppressant therapy or chemotherapy within
5 years within time of screening
11. Presence of excessive skin folds on operative area
12. Intentional exposure of the operative area to ultraviolet radiation (14 days prior to
surgery) within time of screening (ie, sunbathing or tanning bed)
13. Presence of sunburned or peeling skin on operative area
14. Tattoos on operative area
15. Presence of severe, raised scar tissue on operative area which may interfere with pre
and post skin evaluation assessments
16. Presence of an open wound prior to the index surgical procedure on operative area
17. Reported alcohol (= 3 drinks per day) or drug abuse within the past 6 months
18. Topical hypersensitivity or allergy to any disposable components of the dressing
system (eg, silver, polyurethane, polyester, or acrylic adhesive)
19. Topical hypersensitivity or allergy towards any medical adhesive
20. Current enrollment or past participation in this clinical study or any other study
within =30 days
21. Any systemic or local active dermatological disease that might interfere with the
evaluation of the operative area (eg, Meleney's ulcer, scleroderma, chronic urticaria,
psoriasis, skin cancer, eczema, seborrhea, or malignancy)
22. Connective tissue disease or collagen vascular disease (eg, Ehlers-Danlos syndrome,
systemic lupus erythematosus, rheumatoid arthritis)
23. Current or history of hematological disorders or conditions (eg, polycythemia vera,
thrombocythemia, sickle-cell disease)
24. Any Subject with conditions which can potentially result in abnormally pigmented skin
(eg, melasma, vitiligo, pityriasis versicolor)
25. Inability or refusal to wear loose fitting clothing for the duration of the treatment
period
26. Subjects in whom orthopaedic reconstruction is required in addition to total hip or
knee arthroplasty
27. Subjects who are having the total hip or knee arthroplasty as a result of acute
orthopaedic trauma
28. Subjects who have incurred acute orthopaedic trauma (ie, hip fracture) recently or at
any time
29. Subjects who have either acute or chronic open/active wounds present (including
biopsies, ulcerations, etc)
30. Subjects in whom the index procedure is a revision of a total hip or knee arthroplasty
31. Subjects in whom the primary or partial total hip or knee arthroplasty would also be
performed on the contra lateral knee or hip at the same time
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