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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Study Participants | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| embrace device | Device | Adhesive bandage/dressing intended to minimize scar formation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | 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 |
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Inclusion Criteria:
The scar to be revised is:
The subject:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Weintraub, MD | Duet Plastic Surgery | Principal Investigator |
| Angeline Lim, MD | Duet Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duet Plastic Surgery | Palo Alto | California | 94306 | United States |
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All procedures were performed at a single outpatient surgery clinic between September of 2011 and May of 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
After meeting all eligibility criteria, 12 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol, all eligible patients who did not exit the study prematurely. | Posted | Mean | Standard Error | Units on a scale | 6 months |
|
12 months
Adverse Events were reported via phone call or in person at weekly site visits for Neodyne dressing applications. Data was collected by investigators on Adverse Event Clinical Report Forms for each participant. After initial 12 weeks of application visits, data was collected at 6 month and 12 month (optional) intervals.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treated Side | Half of the revised incision was treated with the embrace device. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
The Neodyne Dressing is referred to as the "embrace device."
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Prosak | Neodyne Biosciences | 650-543-7129 | 126 | kprosak@neodynebio.com |
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| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| D002921 | Cicatrix |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| Up to 12 weeks |
| Comparison of Scar Smoothness of Treated Side as Compared to the Control Side | Up to 12 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Half of the revised incision was treated with the embrace device.
| OG001 | Control Side | Half of the revised incision was treated according to the investigator's standard of care. Participant served as his own control. |
|
|
| Secondary | Subject and Investigator Satisfaction With the Aesthetic Results | Not Posted | Up to 12 months |
| Secondary | Ease of Use | Not Posted | Up to 12 months |
| Secondary | Comfort Level Related to Study Device Application, Wear and Removal | Not Posted | Up to 12 weeks |
| Secondary | Comparison of Scar Smoothness of Treated Side as Compared to the Control Side | Not Posted | Up to 12 months |
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | Control Side | Half of the revised incision was treated according to the investigator's standard of care. Participant served as his own control. | 0 | 12 | 3 | 12 |
| Infection | Infections and infestations | Systematic Assessment |
|
| Incision Opened | Surgical and medical procedures | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Peeling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headaches | General disorders | Systematic Assessment |
|
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| D014947 | Wounds and Injuries |