Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE) (IMPROVE)
|Study Design:||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|
- Visual Analogue Scale (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.
 Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006.
- 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 ]
|Study Start Date:||September 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: All Study Participants
Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Device: embrace device
Adhesive bandage/dressing intended to minimize scar formation.
Other Name: Neodyne dressing
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430130
|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|