Linear Cutaneous Wound
Conditions
Keywords
Scar, Cosmesis, Embrace Device, Split Wound, Wound Closure, Cutaneous Wound
Brief summary
The purpose of this study is to determine whether the use of the embrace device after repair of linear cutaneous surgery wounds improves scar cosmesis.
Detailed description
The purpose of this study is to determine whether the use of the embrace device after repair of linear cutaneous surgery wounds improves scar cosmesis. We will use a split wound model, half of the wound is treated with the embrace device and the other half is not treated. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. The scar width and adverse events will also be recorded. Following the surgical repair of cutaneous wounds, scar formation is inevitable and results in varying degrees of aesthetic and/or functional impairment. Numerous treatment modalities have been employed to treat scars. Carbon dioxide and pulse dye lasers, as well as dermabrasion can reduce erythema and irregular topology of the scar surface1,2. Silicone-based products have also been used to treat post-surgical scars, including gels, sheets, and tape3-5. Intralesional steroids are often injected into to induce flattening of a scar6. More recent research has highlighted the impact of mechanical forces and tension on scar formation. In one report, incisions in both pigs and humans were treated with a tension-shielding device and showed a reduction in scarring7. More recently two clinical trials have been published in the plastic surgery literature showing that the use of the embrace device, a silicone-based dressing designed to minimize wound tension, is effective in improving the aesthetic outcome following scar revision surgery8,9. While these initial studies of the embrace device have promising findings, there are significant drawbacks to both studies including small study population, inclusion of patients seeking scar revision (a select group likely predisposed to poor scar cosmesis and not representative of first-time surgical patients), investigator conflict of interest, and the use of a digital software-based scar assessment tool using patients photos that were not standardized with respect to lighting or distance. Therefore, larger studies in first-time surgical patients with standardized photos for scar assessment are required to validate this potentially promising device for improved scar cosmesis.
Interventions
16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.
Without the embrace Scar Therapy Device
Sponsors
Study design
Intervention model description
Each subject receives both types of interventions upon the same scar in order for comparison.
Eligibility
Inclusion criteria
* 18 years of age or older * Able to give informed consent themselves * Patient scheduled for cutaneous surgical procedure along a flat surface suitable to application of the embrace with predicted primary closure. * Able to apply dressings themselves. * Willing to return for follow up visits.
Exclusion criteria
* Mentally handicapped * Unable to understand written and oral English * Incarceration * Under 18 years of age * Pregnant Women * Wounds with predicted closure length less than 3 cm * Patients with known adverse reactions to adhesives * Patients with history of collagen vascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Observer Scar Assessment Score (POSAS) | 3 months | The Patient Observer Scar Assessment Score (POSAS) will be used to compare the cosmetic appearance of scars in the area treated with the device versus the area that was not treated. The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes. |
| Width of the Scar | 3 months | The width of the scar on both sides will also be measured and recorded 1 cm from midline on both sides of the scar |
Countries
United States
Contacts
UC Davis
Participant flow
Recruitment details
Participants recruited for the study had their scars divided into two sections, labeled A and B. These sections were randomized, with one section receiving standard care while the other received the study intervention. A total of 49 participants were included in the study, resulting in 98 wound halves assessed at baseline.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Wound Halves |
| Age, Categorical >=65 years | 25 Wound Halves |
| Age, Categorical Between 18 and 65 years | 24 Wound Halves |
| Age, Continuous | 61.55 years STANDARD_DEVIATION 15.16 |
| Indication for Surgery Excision Surgery | 41 Wound Halves |
| Indication for Surgery Mohs Surgery | 8 Wound Halves |
| Location of Surgical Procedure Abdomen | 3 Wound Halves |
| Location of Surgical Procedure Arm | 14 Wound Halves |
| Location of Surgical Procedure Back | 14 Wound Halves |
| Location of Surgical Procedure Cheek | 0 Wound Halves |
| Location of Surgical Procedure Chest | 9 Wound Halves |
| Location of Surgical Procedure Chin | 0 Wound Halves |
| Location of Surgical Procedure Eyelids | 0 Wound Halves |
| Location of Surgical Procedure Forehead | 0 Wound Halves |
| Location of Surgical Procedure Leg | 10 Wound Halves |
| Location of Surgical Procedure Lip | 0 Wound Halves |
| Location of Surgical Procedure Neck | 2 Wound Halves |
| Location of Surgical Procedure Post-auricular | 0 Wound Halves |
| Location of Surgical Procedure Preauricular | 0 Wound Halves |
| Location of Surgical Procedure Scalp | 0 Wound Halves |
| Location of Surgical Procedure Shoulder | 3 Wound Halves |
| Location of Surgical Procedure Temple | 0 Wound Halves |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Wound Halves |
| Race (NIH/OMB) Asian | 0 Wound Halves |
| Race (NIH/OMB) Black or African American | 0 Wound Halves |
| Race (NIH/OMB) More than one race | 0 Wound Halves |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Wound Halves |
| Race (NIH/OMB) Unknown or Not Reported | 2 Wound Halves |
| Race (NIH/OMB) White | 47 Wound Halves |
| Region of Enrollment United States | 49 Wound Halves |
| Sex: Female, Male Female | 26 Wound Halves |
| Sex: Female, Male Male | 23 Wound Halves |
| Surgeon Experience Attending | 28 Wound Halves |
| Surgeon Experience Fellow | 6 Wound Halves |
| Surgeon Experience Resident | 18 Wound Halves |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 15 / 49 | 8 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |