Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT01640366
Eligibility Criteria:
Inclusion Criteria:
* Female patient's ≥ 18 years old
* The patient is able to understand the trial and is willing to consent to the trial
* Patient has undergone an elective surgical procedure for bilateral reduction mammoplasty
* Patients postsurgical incisions are of similar length
Exclusion Criteria:
* Pregnant or lactating females
* Patients on steroids or other immune modulators known to impact healing which may affect scar appearance
* Patients with tattoos in the area of the incisions
* Patients with skin conditions (Cutis laxa etc.) that would result in poor healing or widened scars
* Patients with a known significant history of scar problems i.e. hypertrophic scaring or keloids
* Patients who in the opinion of the investigator may not complete the study for any reason
* Patients with a known history of poor compliance with medical treatment
* Patients who have participated in this trial previously and who were withdrawn
* 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)
* Incisions that are actively bleeding
* Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
* Incisions \> 12 inches (30cm) max linear dimension
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01640366
Study Brief:
Protocol Section:
NCT01640366