A Study of a Novel Silicone Dressing to Minimize Scar Formation (NCT01399099) | Clinical Trial Compass
CompletedNot Applicable
A Study of a Novel Silicone Dressing to Minimize Scar Formation
United States67 participantsStarted 2011-06
Plain-language summary
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects who have undergone a de novo abdominoplasty.
* Appearance of subject's incision is aesthetically similar across length of incision.
Exclusion Criteria:
* Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
* Subjects diagnosed with scleroderma.
* Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives.
* Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
* Subjects with inability to maintain adequate care of incision.
* Subjects with a body mass index (BMI) \> 30.
* Subjects with a weight loss of greater than or equal to 100 lbs within 6 months from date of abdominoplasty.
* Subjects who currently smoke.
* Subjects taking steroid therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.