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The goal of this clinical trial is to compare Dermabond with non-absorbable sutures in skin closure after brow ptosis surgery. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: Dermabond | Experimental | The surgical wound over one eyebrow will be closed with Dermabond. |
|
| Active Comparator: Non-Absorbable Sutures | Active Comparator | The surgical wound over one eyebrow will be closed with non-absorbable sutures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermabond | Device | Use of Dermabond to close surgical incisions instead of non-absorbable sutures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scar Appearance | Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey. | 10 days |
| Scar Appearance | Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey. | 6 weeks |
| Number of Participants With Complications | Complications of both Dermabond and non-absorbable sutures to include dehiscence and infection | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Timoney, MD | University of Kentucky | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40508 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: Dermabond | The surgical wound over one eyebrow will be closed with Dermabond. Dermabond: Use of Dermabond to close surgical incisions instead of non-absorbable sutures |
| FG001 | Active Comparator: Non-Absorbable Sutures | The surgical wound over one eyebrow will be closed with non-absorbable sutures. Non-Absorbable Sutures: Use of conventional non-absorbable sutures to close surgical incisions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: Dermabond | The surgical wound over one eyebrow will be closed with Dermabond. Dermabond: Use of Dermabond to close surgical incisions instead of non-absorbable sutures |
| BG001 | Active Comparator: Non-Absorbable Sutures |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Appearance | Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey. | Posted | Mean | Full Range | score on a scale | 10 days |
|
6 weeks
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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 | Active Comparator: Dermabond | The surgical wound over one eyebrow will be closed with Dermabond. Dermabond: Use of Dermabond to close surgical incisions instead of non-absorbable sutures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cody Blanchard | University of Kentucky | 859-323-5867 | cody.blanchard@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 30, 2025 | Mar 31, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Non-Absorbable Sutures | Other | Use of conventional non-absorbable sutures to close surgical incisions |
|
The surgical wound over one eyebrow will be closed with non-absorbable sutures. Non-Absorbable Sutures: Use of conventional non-absorbable sutures to close surgical incisions |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Primary | Scar Appearance | Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey. | Posted | Mean | Full Range | score on a scale | 6 weeks |
|
|
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| Primary | Number of Participants With Complications | Complications of both Dermabond and non-absorbable sutures to include dehiscence and infection | Posted | Number | participants | 6 weeks |
|
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Active Comparator: Non-Absorbable Sutures | The surgical wound over one eyebrow will be closed with non-absorbable sutures. Non-Absorbable Sutures: Use of conventional non-absorbable sutures to close surgical incisions | 0 | 3 | 0 | 3 | 0 | 3 |
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