Hypertrophic
Conditions
Keywords
scar, incision, wound healing, scarring, scar revision
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 the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.
Interventions
DEVICEembrace device
Adhesive bandage/dressing intended to minimize scar formation.
Sponsors
Neodyne Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The scar to be revised is: * at least 12 months old * linear and suitable for revision by excision and direct closure * appropriate size and location for Neodyne Dressing * The subject: * age \> 18 and \< 65 years old
Exclusion criteria
* Subjects with a skin disorder that is chronic or currently active. * Subjects who are involved in ongoing litigation in connection with the scar to be revised. * Subjects with a history of collagen vascular disease * Subjects diagnosed with scleroderma * Subject who currently smokes * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | 6 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 |
|---|---|
| Subject and Investigator Satisfaction With the Aesthetic Results | Up to 12 months |
| Ease of Use | Up to 12 months |
| Comfort Level Related to Study Device Application, Wear and Removal | Up to 12 weeks |
| Comparison of Scar Smoothness of Treated Side as Compared to the Control Side | Up to 12 months |
Countries
United States
Participant flow
Recruitment details
All procedures were performed at a single outpatient surgery clinic between September of 2011 and May of 2012.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Infection on Control Side of Incision | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 12 | 3 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
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: 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) | 3.78 Units on a scale | Standard Error 0.35 |
| Control Side | Visual Analogue Scale (VAS) | 5.58 Units on a scale | Standard Error 0.39 |
Secondary
Comfort Level Related to Study Device Application, Wear and Removal
Time frame: Up to 12 weeks
Secondary
Comparison of Scar Smoothness of Treated Side as Compared to the Control Side
Time frame: Up to 12 months
Secondary
Ease of Use
Time frame: Up to 12 months
Secondary
Subject and Investigator Satisfaction With the Aesthetic Results
Time frame: Up to 12 months