Clinical Testing

RETOUCH® Silicone Scar Reduction Sheets received 510K market certification for scar reduction in April 1999. Efficacy testing was documented from June 1999 through October 2000*. Results showed a significant reduction in coloration, height, and appearance in a variety of hypertrophic and keloid scars.


Before

After two months
Kevin Roliard
Kevin was a two-year-old boy who sustained deep second-degree burns in March of 1999 resulting in marked hypertrophic scarring over the anterior chest. The scar was about 4-5 inches long across his upper chest and an inch wide at its widest point. An elasticized garment was used to help hold the RETOUCH® sheets in place. His scar was about seven months old when he began wearing RETOUCH® sheets. He wore the product from October 22, 1999 to December 31, 1999. There was drastic improvement after three months use

Before
After two months
Arlin Dawson
Arlin was a three-year-old girl who received deep second-degree thermal scald burns sustained in a kitchen spill in January of 1999. Arlin suffered burns on her arm, shoulder, and collarbone area. An elasticized garment was used to help hold the RETOUCH® sheets in place. Arlin's scar was almost three months old when she began wearing RETOUCH® sheets. She wore the sheets from April 20, 2000 to June 22, 2000. In July 2000, Dr. Donald Parks confirmed evidence of scar maturation - that is, the scar had become softer, flatter, and lighter in color. The results were only after two months of wearing RETOUCH® sheets.

Before

After four months
Brianna Parks
Brianna was a twenty-year-old college student who suffered scarring as a result of trauma to the head in May of 1999. She had multiple scars extending in different directions on her forehead. Brianna's scars were one month old when she began the RETOUCH® sheet clinical. She wore the product from June 21, 1999 to October 17, 1999. Brianna said that RETOUCH® Silicone Scar Reduction Sheets were, "...comfortable to wear and did not cause any inconvenience." She also added, "I have found that the product has significantly helped the healing process of my scars." Brianna was referred by Dr. Valerie Wright, MD. Waco, Texas.

Additional Testing

Additional medical testing was performed to insure the safety of this product**. Test results were:

  • 85% of test subjects achieved a noticeable difference in scar visibility, color, and height.

Of this 85%...

  • 100% had a reduction in visibility
  • 33% had a reduction in color
  • 33% had a reductin in height
  • All scars were considered "old scars" (over 18 months old) with the youngest at 4 years and the old at 26 years.
*Valerie Wright, M.D. Waco, Texas
Donald Parks, M.D., F.R.C.S.©, F.A.C.S., Director of Hermann Burn Center, Professor & Director, Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Texas Health Science Center, Houston, Texas.

**Additional tests performed at Consumer Product Testing Co., Fairfield, New Jersey are as follows: agar diffusion, primary dermal irritation, acute oral toxicity, sensitization. Also performed were a complete battery of microbiological tests for bacteria, mold/yeast, escherichia coli, salmonella, and staphylococcus aureus.
Consumer Product Testing Co., Fairfield, New Jersey.
Complete test information is available upon request.