N/A
N=12
Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)
Hypertrophic
Bottom Line
View on ClinicalTrials.gov: NCT01430130 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Visual Analogue Scale (VAS) — 3.78; 5.58 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- embrace device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neodyne Biosciences, Inc.
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale (VAS) |
3.78; 5.58 | — |
| SECONDARY Subject and Investigator Satisfaction With the Aesthetic Results |
— | — |
| SECONDARY Ease of Use |
— | — |
| SECONDARY Comfort Level Related to Study Device Application, Wear and Removal |
— | — |
| SECONDARY Comparison of Scar Smoothness of Treated Side as Compared to the Control Side |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01430130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.