A Study of a Novel Silicone Dressing to Minimize Scar Formation

Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer

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.

It is proposed to study a dressing designed to reduce scarring in post-incision skin tissue. It is expected that by managing the incision site during the healing phase, scar formation may be minimized.

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.