The embrace device significantly decreases scarring following scar revision surgery in a randomized controlled trial

Abstract

Background: Mechanically offloading or shielding an incision significantly reduces scarring in both animal and first-in-human studies. Whether or not this strategy would be effective following scar revision surgery was previously unknown. In this article, the authors report that the embrace device, which uses principles of mechanomodulation, significantly improves aesthetic outcomes following scar revision surgery.

Methods: A prospective, open-label, randomized, single-center study was conducted to evaluate the appearance of scars following revision and embrace treatment. Revision surgery was performed on 12 patients, each acting as his or her own control, and outcomes were assessed at 6 months. A visual analogue scale was used to evaluate each scar, rated by four independent surgeons who were not involved in the study.

Results: Evaluation of 6-month scar images by four independent surgeons using the visual analogue scale demonstrated a highly significant improvement in scar appearance following embrace treatment (p < 0.005).

Conclusion: The embrace device represents a powerful new technology for significantly improving scar appearance following revision surgery.

Clinical question/level of evidence: Therapeutic, II.

Figures

Fig. 1

Application of the embrace device. The embrace device is a 16 × 5-cm or 6 × 4-cm silicone elastomeric dressing that adheres to the skin through a pressure-sensitive silicone adhesive. (Above, left) The applicator device is initially opened approximately 60 degrees, and (above, center) the protective liner is peeled away from the adhesive dressing. (Above, right) The top of the applicator is folded all the way back to prestrain the material, and (below, left) the dressing is subsequently applied directly over the center of the scar. (Below, center) Tabs above and below the applicator are pulled away to release the dressing, and (below, right) the applicator device is removed.

Fig. 2

Treatment algorithm. (Above) Scar revision surgery is performed under local anesthesia. (Below, left) Following the procedure, the side of each scar to be treated with the embrace device is selected randomly and the device is applied to approximately half of each incision from 1 to 4 days after the revision procedure. The remaining portion of the incision serves as the control and is treated according to the investigator’s standard of care. (Below, right) After 6 months of treatment, photographs are obtained and evaluated independently by four surgeons using the visual analogue scale (VAS) scoring system.

Fig. 3

Representative photographs illustrating application of the embrace device to a neck scar following thyroidectomy. (Above, left) Preoperative photographs are obtained for each scar before revision surgery. (Above, right) Following the procedure, the side of each scar to be treated with the embrace device is randomly selected and the device is applied to approximately half of each incision, with the other side receiving the standard-of-care treatment determined by the surgeon. Six months after treatment with either the embrace device (center, left) or the investigator’s standard of care (center, right), additional photographs are taken and evaluated independently by four surgeons using the visual analogue scale scoring system. (Below) Embrace-treated (left) and control-treated (right) scar sections exhibit gross differences in appearance.

Fig. 4

Representative photographs illustrating application of the embrace device to a laparotomy scar. (Above, left) Preoperative photographs are obtained for each scar prior to revision surgery. (Above, right) Following the procedure, the side of each scar to be treated with the embrace device is randomly selected and the device is applied to approximately half of each incision, with the other side receiving the standard of care treatment determined by the surgeon. Six months after treatment with either the investigator’s standard of care (center, left) or the embrace device (center, right), additional photographs are taken and evaluated independently by four surgeons using the visual analogue scale scoring system. (Below) Embrace-treated (right) and control-treated (left) scar sections exhibit gross differences in appearance.

Fig. 5

Representative photographs illustrating application of the embrace device to a laparotomy scar. (Above, left) Preoperative photographs are obtained for each scar before revision surgery. (Above, right) Following the procedure, the side of each scar to be treated with the embrace device is selected randomly and the device is applied to approximately half of each incision, with the other side receiving the standard-of-care treatment determined by the surgeon. Six months after treatment with either the embrace device (center, left) or the investigator’s standard of care (center, right), additional photographs are taken and evaluated independently by four surgeons using the visual analogue scale scoring system. (Below) Control-treated (right) and embrace-treated (left) scar sections exhibit gross differences in appearance.

Fig. 6

Visual analogue scale comparison. Photographs of embrace-treated and control-treated scars at 6 months after revision surgery were evaluated by four independent surgeons using the visual analogue scale. Mean visual analogue scale scores for treated scars (3.78) were significantly better than those of control scars (5.58) (*p < 0.005).