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:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT02234193
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adults (\>18 years old) scheduled to undergo elective abdominoplasty surgery at MGH, male or female.
2. Willingness to participate in the study
3. Willingness to undergo biopsies of full-thickness skin tissue from the pre-abdominoplasty skin, and have the biopsy sites marked by tattoos.
4. Informed consent agreement signed by the subject
5. Willingness to follow the treatment and follow-up schedules, and post treatment care requirements
6. Willingness to not use topical or systemic (oral) anti-scarring or anti-inflammatory\* medications during the study period.
Exclusion Criteria:
1. Subjects who are immunocompromised or immunosuppressed\*
2. Subject is unable to comply with treatment, home care or follow-up visits
3. Subject has an infection or other dermatologic condition in the area to be treated
4. Subjects with a personal or family history of keloid formation.
5. Subjects with pre-existing scars, tattoos, birthmarks, or other physical features in the area to be treated, such that the experimental outcome may be confounded.
6. Subjects with a history of coagulopathy, or are taking anticoagulants
7. Subjects taking daily oral aspirin.
8. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
9. Subjects with any contraindications for elective abdominoplasty, as determined by their treating plastic surgeon and/or pre-op anesthesiologist.
10. Subjects with current drug or alcohol addiction.
11. Subjects who are pregnant and/or breastfeeding
12. Subjects with tape adhesive allergies
13. Subjects with known allergies to injectable lidocaine or other topical anesthetics
14. Subjects with uncontrolled or unstable chronic disease such as diabetes, hepatitis, hypertension, etc.
15. Subjects taking oral corticosteroids or topical steroids on the study area.
16. Subjects using prescription or over-the-counter medication or cosmetics containing: retinoids, glycolic acid, salicylic acid or any other remedies that might affect the healing process. (Non-medicated moisturizers are ok).
17. Subjects enrolled in other clinical studies taking any unknown or not-FDA approved medications.
18. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Notes:
\*About Anti-Inflammatory Medication and Immune Status The inflammatory response associated with tissue wounding is known to have substantial effects on the process of scarring, therefore all subjects who are immunocompromised, or undergoing anti-inflammatory/immunosuppressive therapies will be excluded from the study. All new medication should be reported to study doctor before each visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02234193
Study Brief:
Protocol Section:
NCT02234193