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To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiquiBand Flex | Active Comparator | LiquiBand® Flex skin adhesive is indicated for topical application only, to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. It may be used in conjunction with, but not in place of deep dermal sutures. |
|
| Dermabond Advanced | Active Comparator | Dermabond Advancedâ„¢ adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Dermabond Advanced â„¢ adhesive may be used in conjunction with, but not in place of, deep dermal stitches. |
|
| Sutures (Prolene) | Active Comparator | Proleneâ„¢ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiquiBand Flex | Device |
| ||
| Dermabond Advanced |
| Measure | Description | Time Frame |
|---|---|---|
| To compare cosmetic outcomes at follow up | Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale | 3 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Care Center, Beverly Hospital | Beverly | Massachusetts | 01915 | United States |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Sutures (Prolene) | Device |
|