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The purpose of this study is to evaluate how surgical adhesive is used.
In this Case Series Study, clinician experience and subject outcomes will be recorded in the use of a topical skin adhesive (Octylseal) on the closure of skin incisions from General surgical procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Adhesive | Experimental | The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyanoacrylate (Octylseal ) | Device | surgical adhesive |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Length Closure | Primary incision wound length treatment in adult and pediatric general surgery | During Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale | Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst | At Surgery |
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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 |
|---|---|---|---|---|---|---|
| Jersey City Medical Center | Jersey City | New Jersey | 07302 | United States | ||
| Wyckoff Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgical Adhesive | Cyanoacrylate (Octylseal ): surgical adhesive |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Octylseal |
| 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 Length Closure | Primary incision wound length treatment in adult and pediatric general surgery | Posted | Mean | Standard Deviation | milimeters | During Surgery |
|
|
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 | Octylseal | 0 | 34 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment | Of 74 incisions/lacerations treated in 34 patients, there was one (1) documented report of a possible incisional infection (1.4%). The complication was deemed not related to octylseal™. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ed Drower, Clinical Project Director | Medline Industries, Inc | 847-643-3874 | edrower@medline.com |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| New York |
| New York |
| 11237 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale | Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst | All 34 participants | Posted | Count of Participants | Participants | At Surgery |
|
|
|
| 0 |
| 34 |
| 1 |
| 34 |
|
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