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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures

Conditions
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Hypertrophic

Intervention / Treatment
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* Device: embrace device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Study Participants<br>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<br>* Adhesive bandage/dressing intended to minimize scar formation.<br>* Other names: Neodyne dressing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. 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. [1] 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject and Investigator Satisfaction With the Aesthetic Results |  | Up to 12 months | 
| Ease of Use |  | Up to 12 months | 
| Comfort Level Related to Study Device Application, Wear and Removal |  | Up to 12 weeks | 
| Comparison of Scar Smoothness of Treated Side as Compared to the Control Side |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scar, incision, wound healing, scarring, scar revision