Clinical Data

embrace Active Scar Defense has been extensively studied in patients seeking to reduce the appearance of scars

Clinical trials that show you exactly what you can expect from embrace® Active Scar Defense

Multiple peer-reviewed, randomized, controlled clinical trials have demonstrated that by relieving the tension created during the healing process for weeks after surgery, embrace® can dramatically and significantly reduce the visibility of scars.

embrace® shows significant improvement in the appearance of scars

embrace® clinical trials were published in peer-reviewed journals and conducted in patients undergoing real surgical procedures. In addition, the appearance of scars was rated in a blinded fashion by independent surgeons like you who had no vested interest in the study results. Most importantly, patients were asked how satisfied they were with embrace®. And when it comes down to it, isn’t that the most important result?

Just the facts

Level 1 clinical data is the gold standard for evaluating the efficacy of a device. embrace® Active Scar Defense is the only scar treatment on the market proven effective in Level 1 trials. Learn more about clinical trials and why it matters.

of patients and doctors rated the embrace® treated side of the scar as BETTER.*

of the time, patients rated the embrace® dressing as COMFORTABLE to wear.*

of patients would RECOMMEND use of embrace® to family and friends.*

Not all clinical trials are created equal. A quick guide to trials and why the level matters.

embrace® has been extensively studied in patients seeking to reduce the appearance of scars. In a series of four clinical trials, embrace® was used on 188 subjects after various surgeries to validate it’s effectiveness and safety.

1

Level 1
High Quality, randomized controlled trial with systematic review of results

2

Level 2
Case series with pre/post test or only post test

3

Level 3
Retrospective cohort or comparative study

4

Level 3
Lesser quality randomized controlled trial

5

Level 5
Expert opinion developed via consensus process

“Level 1 clinical data is prospective controlled data and is the gold standard for evaluating the efficacy of a device. Embrace® Active Scar Defense was studied in a Level 1 clinical manner and therefore shows that it’s improvement is truly related to using the device.”

Dr. Edward Miranda
Board Certified Plastic Surgeon

embrace clinical trial summary

Level 1 Randomized, peer-reviewed, controlled study

Improve
  • 10 female & male patients
  • Single-center
  • used on scar revision
  • 4, 6 & 12 month follow-up
Refine
  • 67 female & male patients
  • 12 centers
  • used on Abdominoplasty
  • 6 & 12 month follow-up

Level 3 Controlled study

Mona Lisa
  • 10 female patients
  • 2 centers
  • used on Abdominoplasty
  • 6 & 12 month follow-up
Louvre
  • 56 female & male patients
  • 8 centers
  • used on Abdominoplasty (denovo +reduction),breast reduction, breast lift
  • 4, 6 & 12 month follow-up

The embrace® device effectively minimized scarring in both the IMPROVE and REFINE clinical trials with a highly significant difference between embrace®-treated groups and control groups and control groups at both 6 months and 1 year

Supporting Publications

The role of the mechanical environment in scar formation and our approach to scar management — mechanomodulation therapy — has been described and characterized in several peer-reviewed medical journals including, but not limited to:

Longaker, MT et al. A Randomized Controlled Trial of the embrace® Device to Reduce Incisional Scar Formation. Plast Reconstr Surg. 2014 Sep;134(3):536-46. Lim AF, et al. The embrace® Device Significantly Decreases Scarring Following Scar Revision Surgery in a Randomized Controlled Trial. Plast Reconstr Surg. 2014;133:398-405.

Gurtner GC, et al. “Improving Cutaneous Scar by Controlling the Mechanical Environment: Large Animal and Phase 1 Studies.” Annals of Surgery 254-2 (2011): 217-225.

Akaishi, S., Akimoto, M., Ogawa, R. & Hyakusoku, H. The relationship between keloid growth pattern and stretching tension: visual analysis using the finite element method. Ann Plast Surg 60 (2008).

Gurtner G., Werner S., Barrandon Y., Longaker M.T., et al. Wound repair and regeneration. NATURE 453: 314-21 (May 2008).

Aarabi, S., Bhatt KA, Shi Y, Paterno, J., Chang, E.I., Loh S.A., Holmes, J.W., Longaker, M.T., Yee, H., Gurtner, G.C. Mechanical load initiates hypertrophic scar formation through decreased cellular apoptosis. The FASEB Journal J 21:3250-61 (2007).

The significant unmet clinical need for new and effective scar prevention modalities has been described within several peer reviewed medical journals, including, but not limited to:

Young, V.L., Hutchison, J. Insights into Patient and Clinician Concerns about Scar Appearance: Semiquantitative Structured Surveys. Plastic Reconstr Surg. 2009;124(1);256-265.

Rankin, M. and Borah, G. Perceived Functional Impact of Abnormal Facial Appearance. Plastic Reconstr Surg. 2003;111 (7);2140-2146.

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