Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures|
- Difference between the assessments of the scar appearance for the treated as compared to the control incision sites [ Time Frame: 6 months ] [ Designated as safety issue: No ]Incisions will be evaluated by an objective independent expert panel at 6 months post-surgery.
- Subject and investigator satisfaction with the aesthetic results [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Ease of use [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Comfort level related to study device application, wear and removal [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
- Comparison of scar smoothness of treated side as compared to the control side [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]Measured using a scar assessment scale
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Neodyne Dressing applied to portion of closed scar.
Device: Neodyne Dressing
Adhesive bandage/dressing intended to minimize scar formation.
Other Name: Neodyne Device
No Intervention: Control
Standard of care used for portion of closed scar.
It is proposed to study a dressing designed to reduce the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.
|United States, California|
|Duet Plastic Surgery|
|Palo Alto, California, United States, 94306|
|Principal Investigator:||Jennifer Weintraub, MD||Duet Plastic Surgery|
|Principal Investigator:||Angeline Lim, MD||Duet Plastic Surgery|