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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
All Study Participants	embrace device	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of Scar Smoothness of Treated Side as Compared to the Control Side	Up to 12 months
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