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The purpose of this study is to evaluate the effectiveness of on-label use of Surgisealâ„¢ Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure of the topical skin in children presenting in the Emergency Department (ED).
Subjects had SurgiSealâ„¢ applied to their topical skin incisions in the ED. Subjects' wounds were evaluated for bleeding and closure of the incision/wound before patient discharge and 48 hours after the procedure. Further follow up wound closure evaluations were conducted via telephone interview at 5-10 days and 14 days after the ED visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Glue | Experimental | Surgiseal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgiseal | Device | surgical glue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Wound Closure | wound closure measured baseline to 14 days | baseline to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Related to Wound Closure | Adverse events reported | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ed Drower, MS | Medline Industries | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akron Children's Hospital Emergency Department | Akron | Ohio | 44308 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgical Glue | Surgiseal Surgiseal: surgical glue To determine if SurgiSealâ„¢ can effectively seal epidermal wounds in children while not causing any adverse events. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgical Glue | Surgiseal Surgiseal: surgical glue |
| 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 | Number of Participants With Wound Closure | wound closure measured baseline to 14 days | Posted | Number | participants | baseline to 14 days |
|
|
baseline to 14 days
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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 | Surgical Glue | Surgiseal Surgiseal: surgical glue | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ed Drower | Medline Industries, Inc. | 847-643-3874 | edrower@medline.com |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Adverse Events Related to Wound Closure | Adverse events reported | Posted | Number | participants | 14 days |
|
|
|
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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