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This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.
This study will evaluate a new dressing in up to 30 patients who have undergone an abdominoplasty procedure. They will wear the dressing through 8 weeks post surgery and the scar will be evaluated at 3 months post surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLYDe Dressing | Experimental | Investigational Dressing |
|
| Standard of Care | No Intervention | Standard of care comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLYDe Dressing | Device | Wound dressing intended to minimize scar formation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control) | Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels. A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint. | through 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Longaker, MD | Neodyne Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Josh Korman, MD | Mountain View | California | 94040 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21606834 | Derived | Gurtner GC, Dauskardt RH, Wong VW, Bhatt KA, Wu K, Vial IN, Padois K, Korman JM, Longaker MT. Improving cutaneous scar formation by controlling the mechanical environment: large animal and phase I studies. Ann Surg. 2011 Aug;254(2):217-25. doi: 10.1097/SLA.0b013e318220b159. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | The interventions provided consisted of a GLYDe dressing which was randomly assigned to the left or right side of the patient's abdomen. The opposite side of the intervention received the standard of care (SoC). For example, one patient wore a GLYDe Dressing on Left Side, and SoC Right Side while another patient wore GLYDe Dressing Right Side, and SoC Left Side. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | The interventions provided consisted of a GLYDe dressing which was randomly assigned to the left or right side of the patient's abdomen. The opposite side of the intervention received the standard of care (SoC). For example, one patient wore a GLYDe Dressing on Left Side, and SoC Right Side while another patient wore GLYDe Dressing Right Side, and SoC Left Side. |
| 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 | Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control) | Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels. A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint. | Patient population undergoing elective plastic surgery. | Posted | Mean | Standard Deviation | score on a scale | through 12 months |
|
6 months
The incidence and severity of wound related adverse events and infections will be summarized and compared between those that occur on the GLYDe Dressing treated side and those that occur on the control side. All available data will be used. No imputation will be performed for missing data for any analysis.
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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 | GLYDe Dressing | Investigational Dressing GLYDe Dressing: Wound dressing intended to minimize scar formation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, R&D/OPS | Neodyne | 5104564128 | 128 | jzepeda@neodynebio.com |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | SoC (Control) | Standard of care treatment group, used as the control. The opposite side of the intervention received the standard of care (SoC). For example, one patient wore a GLYDe Dressing on Left Side, and SoC on Right Side while another patient wore GLYDe Dressing Right Side, and SoC on Left Side. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Standard of Care | Standard of care comparator | 0 | 12 | 0 | 12 | 0 | 12 |
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