Efficacy of Spray Silicone in Alteration of Burn Scar

At study enrollment, the patient's scar will be evaluated using the vascularity category of
the Vancouver Scar Scale. The vascularity rating is a four item likert scale that rates the
scar as normal (0), pink (1), red (2), or purple (3). Scar height will be measured using a
diagnostic ultrasound unit with a 20MHz transducer.27 Digital photographs will be taken
with a color spectrum scale placed next to the scar. Laser Doppler imaging (LDI) will be
used to assess scar perfusion at the regions of interest to determine whether treatment with
silicone spay results in measureable changes in scar perfusion as well as to establish the
time course over which these changes may be expected to occur. A spray template will then be
created for the patient using thermoplastic material. It will consist of three (3) circles
with an area of .785 inches, spaced one inch apart, which will section off the test areas.
One of the areas will be treated with the spray silicone, one area will be sprayed with
spray saline (to serve as a placebo), the remaining area will not be treated and therefore
will serve as the control. The order in which each area is treated will be determined using
a randomized block, computerized allocation developed by the study statistician. The spray
silicone and spray saline will be applied via containers that conceal the contents and the
patients will not be allowed to observe the application of the silicone or saline. Although
the patient will be blinded to the test areas that have substances applied to them, there
will be no blinding in regard to the control area that receives no treatment. The substances
will be applied by trained investigators each weekday for a 12-week period to ensure the
method of application is consistent. Both substances will be applied at a distance of 1.5
inches from the surface of the skin for a one second period. Patients will be instructed not
to wash the treated area for 24 hours and not to apply pressure garments over the area. The
treated areas will be re-evaluated and photographed every two weeks for a 12 week period.
The clinician conducting the initial scar evaluation and re-evaluations will be blinded to
the scar treatment. Each patient will also complete a scar assessment scale.28 The
patient's participation in the study will be concluded 12 weeks after the initial treatment
and he/she will be given the option of continued use of the spray silicone,
resumption/commencement of pressure garment use or the provision of another appropriate scar
management program. Because burn scar can take several months to years to reach the scar
maturation phase, the patient will still be a candidate for an alternate scar management
program if at the conclusion of this study they see no benefit from the use of spray
silicone. If at any time during the 12-week period the clinician determines that the scar is
worsening, then the patient will be removed from the study and offered another scar
management program.

Inclusion Criteria:

1. Military or civilian

2. Between 18-60 years of age

3. Subjects have experienced a deep partial thickness burn injury with a minimal size
2x6 inches in dimension

4. Burn wounds must have healed by secondary intention

5. Available for initial scar evaluation and bi-weekly assessments (30 minutes) and
application of silicone and saline every weekday (5 minutes)

Exclusion Criteria:

1. <18 or >60 years

2. Available burn scar size is less then 2x6 inches

3. Burn wounds healed by sheet grafting

4. Unavailable for initial scar evaluation and bi-weekly assessments (30 minutes) and
application of silicone and saline every weekday (5 minutes)

5. Pre-existing medical conditions that have the potential to impair healing (i.e.
Diabetes, Peripheral Arterial Disease, etc).

6. Pregnant women will be excluded from the study because of the potential for pregnancy
hormones to exacerbate the burn scar