Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)

Completed · Not applicable

Conditions studied: Hypertrophic

In brief

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.

Key facts

Study ID

NCT01430130

Run by

Neodyne Biosciences, Inc.

People needed

12

Starts

2011-09-01

Expected to finish

2012-11-01

Last updated by the study team

2014-11-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The scar to be revised is:
• at least 12 months old
• linear and suitable for revision by excision and direct closure
• appropriate size and location for Neodyne Dressing
• The subject:
• age > 18 and < 65 years old

You may not qualify if…

• Subjects with a skin disorder that is chronic or currently active.
• Subjects who are involved in ongoing litigation in connection with the scar to be revised.
• Subjects with a history of collagen vascular disease
• Subjects diagnosed with scleroderma
• Subject who currently smokes
• 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.

Where it is running

• Duet Plastic Surgery — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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