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Results from our earlier study indicate that the standard deviation of the paired differences in visual analogue scale scores would not be expected to exceed 1. Should the embrace dressing, on average, show an improvement of at least 0. The visual analogue scale results are expressed as mean values for the treatment and control incisions, and the mean difference is presented along with 95 percent confidence intervals.
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No adjustments were made for multiple hypothesis testing. Between June of and May of , a total of 67 subjects were initially enrolled in this study, with 36 subjects completing at least 5 weeks of dressing application and providing the final month study photographs Fig. Procedures were performed by 12 plastic surgeons at 12 surgical centers in the United States. See Table, Supplemental Digital Content 3 , which shows clinical site distribution, http: Subject ages ranged from 24 to 65 years, with an average age of Based on self-reported race and ethnicity data using options defined by the investigator , Flow diagram of clinical trial.
Seventy-three subjects were initially assessed for eligibility, with four excluded because of a body mass index BMI in excess of 30 and two excluded after canceling surgery. In addition, two were excluded after enrollment but before treatment one because of a body mass index out of range and the other as a result of missing the treatment window.
A total of 65 subjects underwent randomization self as control , with half of each incision allocated to receive either embrace or control treatment. Eighteen subjects did not complete the study, with 13 discontinuing because of skin irritation, one because of a wound-site infection, and four for miscellaneous reasons.
An additional 11 subjects completed treatment but were subsequently lost to follow-up, resulting in 36 subjects included in the final analysis. Of the 31 subjects that did not complete the month study exit, two were exited before treatment one because of a body mass index out of range and the other as a result of missing the treatment window. Early termination occurred in an additional 18 subjects. Of these, 13 were related to irritation or a rash, one because of a wound-site infection, and four for miscellaneous reasons.
An additional 11 subjects completed treatment but did not return for their month follow-up. Scar images were obtained at 6 and 12 months after the abdominoplasty procedure, and the embrace-treated and control-treated images for all subjects were evaluated independently in a blinded fashion by three board-certified plastic surgeons using the visual analogue scale Figs.
That is, each image was graded not in comparison to the contralateral side but as a single image. The mean visual analogue scale score for treated scars 2. Photographic evaluation.
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Above and second row Patient at 6 months after abdominoplasty surgery. Above entire view of abdominoplasty scar. Second row , left The embrace-treated side and second row , right the control-treated side. The mean visual analogue scale scores for treated and control incisions were 2. Overall subject Patient and Observer Scar Assessment Scale scores were 5 for the treated and 10 for the control incision.
Overall investigator Patient and Observer Scar Assessment Scale scores were 2 for the treated and 5 for the control incision. Third row and below Patient at 12 months following abdominoplasty surgery. Third row Entire view of abdominoplasty scar. Below , left The embrace-treated side and below , right the control-treated side.
Overall subject Patient and Observer Scar Assessment Scale scores were 2 for the treated and 7 for the control incision. Overall investigator Patient and Observer Scar Assessment Scale scores were 2 for the treated and 6 for the control incision. Above Entire view of abdominoplasty scar. The mean visual analogue scale scores for treated and control incisions were 4. Overall subject Patient and Observer Scar Assessment Scale scores were 10 for the treated and 10 for the control incision. Overall investigator Patient and Observer Scar Assessment Scale scores were 2 for the treated and 4 for the control incision.
Third row and below Patient at 12 months after abdominoplasty surgery. Overall subject Patient and Observer Scar Assessment Scale scores were 4 for the treated and 10 for the control incision. Overall investigator Patient and Observer Scar Assessment Scale scores were 1 for the treated and 4 for the control incision. In addition to the objective visual analogue scale photographic analysis, treating physicians and subjects were asked to evaluate each scar using the Patient and Observer Scar Assessment Scale system.
This evaluation is of importance because the treating physician uses three-dimensional examination and palpation to grade the scar. Similarly, subjects grade the scars based on real-life visual and topographic information. Investigators and subjects each rated embrace-treated and control-treated scars on seven categories using the Patient and Observer Scar Assessment Scale at 7, 9, 11, and 13 weeks, and at 6 and 12 months Table 2.
The evaluations at multiple time points allowed comparison of the difference between the embrace-treated incisions and the control-treated incisions over time. Figure 5 shows that, in the opinions of the treating surgeons and subjects, the difference remained consistent over time. This is powerful, as it was important to know that any advantage at the end of treatment is not dissipated over a larger sample of treatment weeks. In addition, the overall Patient and Observer Scar Assessment Scale scores for both investigators and subjects decreased monotonically from 9 weeks to 12 months for embrace-treated scars.
Evolution of scar appearance over time. Error bars represent standard error of the mean. Tx , treatment; Ctrl , control. To determine whether the embrace device exhibited differential efficacy according to certain subject variables, we constructed a linear model to evaluate whether age, race, body mass index, or Fitzpatrick skin type were predictive of month visual analogue scale scores.
These results suggest that the effect of the embrace device is not specific to one or more subpopulations identifiable by these variables. We examined whether the embrace device would be more effective in reducing scarring for patients who healed with scars that were rated worse by the investigator surgeon on the Patient and Observer Scar Assessment Scale. Importantly, in these subjects, the difference in Patient and Observer Scar Assessment Scale score was more dramatic both clinically and statistically embrace-treated, 2.
Furthermore, we evaluated whether subjects who dropped out of the study may have been those preinclined to experience less improvement with the embrace device, thus confounding our final evaluation. As 9 weeks was the first statistically significant time point for overall subject evaluation with the Patient and Observer Scar Assessment Scale, we used these data to compare the ratings of those subjects that did return for final evaluation at 12 months and those that did not. These data suggest that early dropouts did not play a strong role in confounding our analysis.
Subjects were asked to rate their general satisfaction by answering three questions regarding their study participation. They were asked to compare the embrace-treated side with the control-treated side with regard to the minimization of scarring of their incision. Seventy-one percent of subjects Second, they were asked how likely they would be to recommend the embrace treatment to a friend. Seventy-four percent of subjects Third, they were asked, if they were to have another procedure that might leave a scar, how likely would they be to use the embrace treatment again.
Seventy-seven of subjects Because the embrace device is a topical treatment with no active chemical or biological agents, we did not expect to see any serious adverse events, and in fact none were reported. Skin irritation sufficient to terminate treatment occurred in 13 subjects, one subject developed a wound-site infection leading to withdrawal from the study, and one experienced an allergic reaction.
To our knowledge, this study represents the first pivotal level I evidence for postoperative scar reduction.
Our data strongly support that the embrace device significantly reduces scarring after excisional wound closure. The embrace device has a mechanism of action that is based on surgical principles currently used to minimize scarring. During an operation, surgeons strive to make incisions that follow the relaxed tension lines on the body, so-called Langer lines.
This strategy is used because tension is well known to increase scarring. The embrace device is designed to shield the healing incision from the natural tension that is inherent in any break in skin that must be pulled together to close a wound.
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Previous preclinical and first-in-human data initially demonstrated that this mechanism of action was effective in scar mitigation in both pigs and humans. Abdominoplasty incisions were selected for this trial for several reasons. First, the wounds are closed under considerable tension, which presents the most challenging test of a product intended to modulate the mechanical environment of a healing wound. One could postulate that if the device was effective in shielding the healing wound under this challenging mechanical environment, it would be effective in incisions closed under less strain.
Second, the length of the incision is ideal for a randomized controlled design so that each subject can serve as his or her own control. This is important, as it allows for the most rigorous direct comparison of two treatment arms on the same subject and completely avoids subject-to-subject variability as a confounding factor when comparing two treatment types. Furthermore, because of the high-tension closure, abdominoplasty scars are well known to be wide and surgeons have developed their own individual postoperative approaches for scar mitigation.
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