N/A
N=67
A Study of a Novel Silicone Dressing to Minimize Scar Formation
Hypertrophic
Bottom Line
View on ClinicalTrials.gov: NCT01399099 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Visual Analogue Scale (VAS) — 2.90; 3.29 score 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
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale (VAS) |
3.18; 3.85 | — |
| PRIMARY Visual Analogue Scale (VAS) |
3.18; 3.85 | — |
| SECONDARY Patient and Observer Scar Assessment Scale (POSAS) - Patient Results |
1.00; 1.06; 1.40; 1.29; 3.80; 4.31 | — |
| SECONDARY Patient and Observer Scar Assessment Scale (POSAS) - Patient Results |
1.00; 1.06; 1.40; 1.29; 3.80; 4.31 | — |
| SECONDARY Patient and Observer Scar Assessment Scale (POSAS) - Observer Results |
1.67; 2.25; 1.61; 2.69; 3.36; 3.50 | — |
| SECONDARY Patient and Observer Scar Assessment Scale (POSAS) - Observer Results |
1.67; 2.25; 1.61; 2.69; 3.36; 3.50 | — |
| SECONDARY Patient Satisfaction - Scar Minimization |
14; 11; 10; 0; 0 | — |
| SECONDARY Patient Satisfaction - Recommend |
15; 11; 5; 2; 2 | — |
| SECONDARY Patient Satisfaction - Use Again |
15; 12; 3; 3; 2 | — |
| SECONDARY Patient Satisfaction - Scar Minimization |
14; 11; 10; 0; 0 | — |
| SECONDARY Patient Satisfaction - Recommend |
15; 11; 5; 2; 2 | — |
| SECONDARY Patient Satisfaction - Use Again |
15; 12; 3; 3; 2 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT01399099). 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.