A Study of a Novel Silicone Dressing to Minimize Scar Formation (REFINE)

Neodyne Biosciences

Status

Completed

Conditions

Hypertrophic

Treatments

Device: embrace device

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT01399099

CA003

00016580 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

67 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.