A Study of a Novel Silicone Dressing to Minimize Scar Formation

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 scarring in post-incision skin tissue. It is expected that by managing the incision site during the healing phase, scar formation may be minimized.

Official Title
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Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer

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: Subjects who have undergone a de novo abdominoplasty. Appearance of subject's incision is aesthetically similar across length of incision. Exclusion Criteria: Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus. Subjects diagnosed with scleroderma. 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. Subjects with a body mass index (BMI) > 30. Subjects with a weight loss of greater than or equal to 100 lbs within 6 months from date of abdominoplasty. Subjects who currently smoke. Subjects taking steroid therapy.

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: Treatment
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 abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator's standard of care. Participant served as his 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. | 12 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, post-surgical