Summary:
ICON Early Phase Services is conducting a device research study for healthy female adults age 18 and over. This study is being done to test a wearable device designed to provide better wound care. The study will be conducted using females with either natural or augmented breasts.
Vital signs, physical examinations, pregnancy and drug screens will be performed. Urine samples will also be obtained during this study.
Participants will complete:
- 1 screening visit
- outpatient visit #1 (8-hour visit)
- outpatient visits #2 and #3 (4-hour visits)
- 14 days of continuous wear of a breast dressing
If ICON does not have your medical records on file, you will need to provide medical records at screening.
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a healthy female adult, meaning no significant medical conditions
- I am 18 years old or older
- My BMI is between 18.0 and 32.0 kg/m2 and I weigh at least 110 lbs.
- I have not participated in another clinical trial within 30 days to study start
- I do not smoke or use any tobacco/nicotine products. I agree not to smoke for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility.
- I am non-fertile, or, I agree to use birth control during the study until the last study visit
- I am not pregnant or breastfeeding
- I agree to avoid activities that will require excessive movement, cause excessive sweating, or exposure to water such as contact sports, swimming, aerobics, running, or similar activities that may impact the performance of the dressing
- I am able to communicate effectively in English with the study personnel
- I am able to drive myself or have someone bring me to the clinic during my participation
- I agree to avoid prolonged contact with water at the where the dressing is applied (such as soaking in a bathtub or hot tub, swimming) for the duration of the study
- I agree to avoid tanning lotions, exposure to ultraviolet radiation from the sun, or artificial sources such as a tanning bed
- I am willing to wear loose clothing around the breast for the duration of the study (no bras, sports bras, underwire bras)
- I do not have any clinically significant conditions or diseases
- I do not have a history or presence of any dermatological disease that might interfere with the evaluation of the test site (such as psoriasis, skin cancer, etc.)
- I do not have a history or presence of connective tissue disease or collagen vascular disease (such as systemic lupus erythematosus, rheumatoid arthritis)
- I do not have a history or presence of any blood disorders (such as sickle cell disease) or immunosuppressive disorder
- I do not have Type I or II diabetes
- I do not have any condition that could potentially result in abnormal pigmented skin
- I do not have a pre-existing or dormant skin condition near or around the application area (such as psoriasis, eczema, atopic dermatitis)
- I do not have damaged skin in or around the application area (such as sunburn, peeling skin, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, wounds, lesions, severe raised scar tissue)
- I have not had recent exposure to ultraviolet light either from the sun or from a tanning bed
- I have not had recent topical treatment on the test area (such as laser hair or tattoo removal)
- I have not recently used topical steroid treatments or topical antibiotics on the test area
- I have not recently used oral steroids
- I do not have a history of cancer that required immunosuppressant therapy or chemotherapy
- I do not have allergies or hypersensitivity to the materials used in the dressing (such as, medical adhesive, polyurethane, silver, latex, foam, drape material)
- I do not have a recent history of substance abuse or treatment (including alcohol).
It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures. Frequently, subjects do not qualify because of medical history or minor changes in vital signs and lab tests. Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit. Additionally, no guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for lost time, travel or failure to qualify.
To determine if you fully qualify at screening, it will be necessary to obtain urine samples. Be sure to bring all of your medications with you to your screening appointment.
Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a government issued identification card such as a driver's license, state issued ID card, or passport. Also, be advised that we cannot accept a military ID as we are legally prohibited from copying that form of identification for our records.*Note: As of Nov. 01, 2018 our policy has changed and MILITARY IDs ARE NOW ALLOWED. You will be required to show this same photo ID at all study visits.
You will be filling out paperwork for the study. Please arrive at least 30 minutes in advance of your screening appointment. If you are late for your appointment you may not be seen or may need to reschedule.
Be advised that you may need to provide medical records as part of the screening process for this study. If possible, please bring your full medical records with you to your screening appointment. If you cannot bring your records with you, you must provide them before you can admit to the study. Note that full medical records include surgical reports.
Qualified Participants May Receive:
Qualified participants may be compensated up to $2,600 for time and travel.