Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE) (IMPROVE)
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|ClinicalTrials.gov Identifier: NCT01430130|
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : November 28, 2014
Last Update Posted : November 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic||Device: embrace device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
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
- Visual Analogue Scale (VAS) [ Time Frame: 6 months ]
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 ]
- Ease of Use [ Time Frame: Up to 12 months ]
- Comfort Level Related to Study Device Application, Wear and Removal [ Time Frame: Up to 12 weeks ]
- Comparison of Scar Smoothness of Treated Side as Compared to the Control Side [ Time Frame: Up to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|