Hypertrophic
Conditions
Keywords
scar, incision, wound healing, scarring, post-surgical
Brief summary
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.
Detailed description
It is proposed to study a dressing designed to reduce scarring in post-incision skin tissue. It is expected that by managing the incision site during the healing phase, scar formation may be minimized.
Interventions
DEVICEembrace device
Adhesive bandage/dressing intended to minimize scar formation.
Sponsors
U.S. Army Medical Research and Development Command
Neodyne Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who have undergone a de novo abdominoplasty. * Appearance of subject's incision is aesthetically similar across length of incision.
Exclusion criteria
* Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus. * Subjects diagnosed with scleroderma. * Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives. * Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application. * Subjects with inability to maintain adequate care of incision. * Subjects with a body mass index (BMI) \> 30. * Subjects with a weight loss of greater than or equal to 100 lbs within 6 months from date of abdominoplasty. * Subjects who currently smoke. * Subjects taking steroid therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | 12 months | Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006\[1\]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome. \[1\] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | 6 Months | The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively \[1\]. The POSAS criteria evaluated by the patients in this study were pain, itching, color, stiffness, thickness, irregularity, and overall opinion. The Patient and Observer Scar Assessment Scale (POSAS) ranges from 1 to 10 with 10 being the worst imaginable or most different. \[1\] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184. |
| Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | 6 Months | The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively \[1\]. The POSAS criteria evaluated by the observers in this study were vascularity, pigmentation, thickness, relief, pliability, surface area, and an overall opinion. \[1\] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184. |
| Patient Satisfaction - Scar Minimization | 6 Months | Subjects were were asked to compare the embrace-treated side with the control-treated side with regards to their satisfaction with the scar minimization on their incision. |
| Patient Satisfaction - Recommend | 6 Months | Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend. |
| Patient Satisfaction - Use Again | 6 Months | Subjects were asked if they were to have another procedure that would leave a scar how likely would they be to use embrace treatment again. |
Countries
United States
Participant flow
Recruitment details
Procedures were performed by 12 surgeons at 12 surgery centers between June 2011 and May of 2012.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Half of the abdominoplasty incision was treated with the embrace device. Half of the abdominoplasty incision was treated according to the investigator's standard of care. Participant served as his own control. | 67 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Infection | 1 |
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Miscellaneous | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Skin Irritation | 13 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 67 participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 67 |
| other Total, other adverse events | 40 / 67 | 40 / 67 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 |
Outcome results
Primary
Visual Analogue Scale (VAS)
Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006\[1\]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome. \[1\] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006.
Time frame: 12 months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Side | Visual Analogue Scale (VAS) | 2.90 score on a scale | Standard Deviation 1.36 |
| Control Side | Visual Analogue Scale (VAS) | 3.29 score on a scale | Standard Deviation 1.55 |
Primary
Visual Analogue Scale (VAS)
Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006\[1\]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome. \[1\] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006.
Time frame: 6 months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Side | Visual Analogue Scale (VAS) | 3.18 score on a scale | Standard Deviation 1.71 |
| Control Side | Visual Analogue Scale (VAS) | 3.85 score on a scale | Standard Deviation 1.77 |
Secondary
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results
The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively \[1\]. The POSAS criteria evaluated by the observers in this study were vascularity, pigmentation, thickness, relief, pliability, surface area, and an overall opinion. \[1\] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.
Time frame: 6 Months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Overall Opinion | 1.98 score on a scale | Standard Deviation 0.62 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Thickness | 3.07 score on a scale | Standard Deviation 2.78 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Vascularity | 2.07 score on a scale | Standard Deviation 0.72 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Pigmentation | 2.16 score on a scale | Standard Deviation 1.11 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Relief | 2.78 score on a scale | Standard Deviation 1.52 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Pliability | 2.09 score on a scale | Standard Deviation 1 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Surface Area | 3.07 score on a scale | Standard Deviation 2.29 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Pigmentation | 3.13 score on a scale | Standard Deviation 1.58 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Relief | 3.62 score on a scale | Standard Deviation 1.81 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Overall Opinion | 3.02 score on a scale | Standard Deviation 1.45 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Surface Area | 3.42 score on a scale | Standard Deviation 1.76 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Vascularity | 2.96 score on a scale | Standard Deviation 1.46 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Pliability | 2.98 score on a scale | Standard Deviation 1.45 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Thickness | 3.73 score on a scale | Standard Deviation 2.19 |
Secondary
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results
The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively \[1\]. The POSAS criteria evaluated by the observers in this study were vascularity, pigmentation, thickness, relief, pliability, surface area, and an overall opinion. \[1\] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.
Time frame: 12 Months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Thickness | 3.36 score on a scale | Standard Deviation 3.2 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Pliability | 1.67 score on a scale | Standard Deviation 0.68 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Pigmentation | 1.61 score on a scale | Standard Deviation 0.77 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Surface Area | 2.92 score on a scale | Standard Deviation 2.18 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Relief | 2.56 score on a scale | Standard Deviation 1.61 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Overall Opinion | 1.61 score on a scale | Standard Deviation 0.55 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Vascularity | 1.67 score on a scale | Standard Deviation 0.63 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Overall Opinion | 2.50 score on a scale | Standard Deviation 1.38 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Vascularity | 2.25 score on a scale | Standard Deviation 1.18 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Pigmentation | 2.69 score on a scale | Standard Deviation 1.98 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Thickness | 3.50 score on a scale | Standard Deviation 2.56 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Relief | 3.11 score on a scale | Standard Deviation 1.86 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Pliability | 2.25 score on a scale | Standard Deviation 1 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Observer Results | Surface Area | 2.81 score on a scale | Standard Deviation 1.62 |
Secondary
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results
The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively \[1\]. The POSAS criteria evaluated by the patients in this study were pain, itching, color, stiffness, thickness, irregularity, and overall opinion. The Patient and Observer Scar Assessment Scale (POSAS) ranges from 1 to 10 with 10 being the worst imaginable or most different. \[1\] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.
Time frame: 6 Months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Color | 4.75 score on a scale | Standard Deviation 2.37 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Thickness | 3.34 score on a scale | Standard Deviation 2.12 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Itch | 1.41 score on a scale | Standard Deviation 1.24 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Irregularity | 3.66 score on a scale | Standard Deviation 2.38 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Stiffness | 2.91 score on a scale | Standard Deviation 1.95 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Overall | 3.70 score on a scale | Standard Deviation 2.21 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Pain | 1.05 score on a scale | Standard Deviation 0.21 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Overall | 4.91 score on a scale | Standard Deviation 2.75 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Pain | 1.21 score on a scale | Standard Deviation 0.8 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Itch | 1.52 score on a scale | Standard Deviation 1.47 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Color | 5.21 score on a scale | Standard Deviation 2.53 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Stiffness | 4.48 score on a scale | Standard Deviation 2.6 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Thickness | 4.30 score on a scale | Standard Deviation 2.3 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Irregularity | 4.61 score on a scale | Standard Deviation 2.64 |
Secondary
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results
The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively \[1\]. The POSAS criteria evaluated by the patients in this study were pain, itching, color, stiffness, thickness, irregularity, and overall opinion. \[1\] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.
Time frame: 12 Months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Color | 3.80 score on a scale | Standard Deviation 2.21 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Thickness | 2.86 score on a scale | Standard Deviation 2.02 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Itch | 1.40 score on a scale | Standard Deviation 1.24 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Irregularity | 3.46 score on a scale | Standard Deviation 2.19 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Stiffness | 2.63 score on a scale | Standard Deviation 2.06 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Overall | 3.66 score on a scale | Standard Deviation 2.35 |
| Treated Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Pain | 1.00 score on a scale | Standard Deviation 0 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Overall | 4.66 score on a scale | Standard Deviation 2.8 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Pain | 1.06 score on a scale | Standard Deviation 0.24 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Itch | 1.29 score on a scale | Standard Deviation 1.2 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Color | 4.31 score on a scale | Standard Deviation 2.49 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Stiffness | 3.77 score on a scale | Standard Deviation 2.43 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Thickness | 3.97 score on a scale | Standard Deviation 2.48 |
| Control Side | Patient and Observer Scar Assessment Scale (POSAS) - Patient Results | Irregularity | 4.29 score on a scale | Standard Deviation 2.58 |
Secondary
Patient Satisfaction - Recommend
Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.
Time frame: 6 Months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Side | Patient Satisfaction - Recommend | Very Likely | 16 Participants |
| Treated Side | Patient Satisfaction - Recommend | Likely | 19 Participants |
| Treated Side | Patient Satisfaction - Recommend | Neither likely nor unlikely | 4 Participants |
| Treated Side | Patient Satisfaction - Recommend | Unlikely | 3 Participants |
| Treated Side | Patient Satisfaction - Recommend | Very Unlikely | 2 Participants |
Secondary
Patient Satisfaction - Recommend
Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.
Time frame: 12 Months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Side | Patient Satisfaction - Recommend | Very Likely | 15 Participants |
| Treated Side | Patient Satisfaction - Recommend | Likely | 11 Participants |
| Treated Side | Patient Satisfaction - Recommend | Neither Likely nor Unlikely | 5 Participants |
| Treated Side | Patient Satisfaction - Recommend | Unlikely | 2 Participants |
| Treated Side | Patient Satisfaction - Recommend | Very Unlikely | 2 Participants |
Secondary
Patient Satisfaction - Scar Minimization
Subjects were were asked to compare the embrace-treated side with the control-treated side with regards to their satisfaction with the scar minimization on their incision.
Time frame: 6 Months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Side | Patient Satisfaction - Scar Minimization | Very Satisfied | 14 Participants |
| Treated Side | Patient Satisfaction - Scar Minimization | Satisfied | 18 Participants |
| Treated Side | Patient Satisfaction - Scar Minimization | Neither Satisfied nor Dissatisfied | 11 Participants |
| Treated Side | Patient Satisfaction - Scar Minimization | Dissatisfied | 1 Participants |
| Treated Side | Patient Satisfaction - Scar Minimization | Very Dissatisfied | 0 Participants |
Secondary
Patient Satisfaction - Scar Minimization
Subjects were were asked to compare the embrace-treated side with the control-treated side with regards to their satisfaction with the scar minimization on their incision.
Time frame: 12 Months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Side | Patient Satisfaction - Scar Minimization | Dissatisfied | 0 Participants |
| Treated Side | Patient Satisfaction - Scar Minimization | Very Satisfied | 14 Participants |
| Treated Side | Patient Satisfaction - Scar Minimization | Satisfied | 11 Participants |
| Treated Side | Patient Satisfaction - Scar Minimization | Neither Satisfied nor Dissatisfied | 10 Participants |
| Treated Side | Patient Satisfaction - Scar Minimization | Very Dissatisfied | 0 Participants |
Secondary
Patient Satisfaction - Use Again
Subjects were asked if they were to have another procedure that would leave a scar how likely would they be to use embrace treatment again.
Time frame: 6 Months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Side | Patient Satisfaction - Use Again | Very likely | 22 Participants |
| Treated Side | Patient Satisfaction - Use Again | Likely | 10 Participants |
| Treated Side | Patient Satisfaction - Use Again | Neither likely nor unlikely | 4 Participants |
| Treated Side | Patient Satisfaction - Use Again | Unlikely | 5 Participants |
| Treated Side | Patient Satisfaction - Use Again | Very Unlikely | 3 Participants |
Secondary
Patient Satisfaction - Use Again
Subjects were asked if they were to have another procedure that would leave a scar how likely would they be to use embrace treatment again.
Time frame: 12 Months
Population: Per protocol, all eligible patients who did not exit the study prematurely.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Side | Patient Satisfaction - Use Again | Likely | 12 Participants |
| Treated Side | Patient Satisfaction - Use Again | Neither Likely nor Unlikely | 3 Participants |
| Treated Side | Patient Satisfaction - Use Again | Unlikely | 3 Participants |
| Treated Side | Patient Satisfaction - Use Again | Very Unlikely | 2 Participants |
| Treated Side | Patient Satisfaction - Use Again | Very Likely | 15 Participants |