Clinical Study – Dermatix® Formulation Silicone Gel
The Study
A randomised, placebo-controlled, double-blind, prospective trial of Silicone Gel for prevention of hypertrophic scar development in median sternotomy wounds was carried out.
Asian patients were chosen for the study as hypertrophic scarring is more prevalent within this portion of the population.
100 wounds in 50 patients randomised equally to matching active and control gels applied to upper and lower half of each sterna wound, thus selection and assessment biases and confounders were eliminated.
| Wounds assessed using Vancouver Scar Scale: Scores as below |
|
0 |
1 |
2 |
3 |
4 |
5 |
| Pigmentation |
Normal |
Hypo-pigmentation |
Hyper-pigmentation |
|
|
|
| Vascularity |
Normal |
Pink |
Red |
Purple |
|
|
| Pliability |
Normal |
Supple |
Yielding |
Firm |
Banding (rope-like) |
Contracture |
| Height |
Flat |
1 - 2 mm |
2 - 5 mm |
>5 mm |
|
|
| Pain |
None |
Occasional |
Requires medication |
|
|
|
| Itchiness |
None |
Occasional |
Requires medication |
|
|
|
Chan KY et al. Plastic Reconstructive Surgery 2005; 116: 1013 - 20
The Results
The study found that the semi-liquid form of Silicone Gel proved to be effective in preventing hypertrophic scar development in sternotomy wounds.
There were no side effects found when this type of Silicone Gel was used and patient compliance was satisfactory.
Chan KY et al. Plastic Reconstructive Surgery 2005; 116: 1013 - 20
