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Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
Subjects were approached for recruitment in the ED when discussing closure options by the physician. Only subjects deemed appropriate for skin glue closures by their treating physician were approached.Subjects were followed at 48 hours post-procedure, 5-10 days, and at 14 days following the ED visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin Affix | Experimental | Surgical adhesive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Affix | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Closure at Discharge | Wounds remained closed following application of Skin Affix | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Following Application | Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain. | 15 minutes Post Application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Schrock, MD | Metro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth System | Cleveland | Ohio | 44109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Skin Affix | Surgical adhesive (Skin Affix) applied during wound closure in ED |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Skin Affix | Surgical adhesive Skin Affix |
| 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 | Wound Closure at Discharge | Wounds remained closed following application of Skin Affix | Posted | Number | percent of participants | 14 days |
|
|
1 year
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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 | Skin Affix | Surgical adhesive Skin Affix | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural bleeding | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori Rotolo | Medline Industries, Inc. | 8476434640 | lrotolo@medline.com |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | Change in Pain Following Application | Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain. | Participants were asked 15 min after application to rate any change in pain as decreased, increased or no change. | Posted | Number | percent of participants | 15 minutes Post Application |
|
|
|
| 35 |
| 0 |
| 35 |
| 9 |
| 35 |
| Dihiscence | Surgical and medical procedures | Systematic Assessment |
|
| Infection | Surgical and medical procedures | Systematic Assessment |
|
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| Title | Measurements |
|---|
|