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Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with stitches in Port a Cath patients, who, as a population, are at increased risk for complications. All adult patients who present for initial Port a Cath placement during the recruitment period will be eligible to participate in the study. Subjects will be randomized to either skin incision closure with standard stitches or closure with skin glue. Time to complete skin closure and costs of closure will be compared. Patients will be evaluated approximately one month and three months from the procedure to assess for complications of wound breakdown or infection, as well as for the appearance of the Port a Cath incision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture | Active Comparator | Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture |
|
| Octylcyanoacrylate | Experimental | Skin incision closure with topic skin adhesive Octylcyanoacrylate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octylcyanoacrylate | Device | Skin incision closure with topic skin adhesive Octylcyanoacrylate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complication of Wound Dehiscence | To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures. | 3 months |
| Number of Participants With Complication of Infection | To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Healing-incision Cosmesis Score by Visual Analogue Scale | To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome. | 3 months |
| Closure Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Kim, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Suture | Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture |
| FG001 | Octylcyanoacrylate | Skin incision closure with topic skin adhesive Octylcyanoacrylate Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Suture | Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture |
| BG001 | Octylcyanoacrylate |
| 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 | Number of Participants With Complication of Wound Dehiscence | To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures. | Posted | Number | participants | 3 months |
|
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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 | Suture | Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture |
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Small sample size, underpowered to demonstrate small differences in rates of dehiscence or infection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Kim | Duke University Medical Center | 9196847424 | charles.kim@duke.edu |
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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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| Suture | Procedure | Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture |
|
To compare closure time and associated costs between these two methods of skin closure. |
| Baseline |
| Closure Materials Cost | Per unit cost for suture and octylcyanoacrylate | Baseline |
Skin incision closure with topic skin adhesive Octylcyanoacrylate Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Complication of Infection | To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures. | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Healing-incision Cosmesis Score by Visual Analogue Scale | To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome. | Only participants who completed the Healing-incision cosmesis score by Visual Analogue Scale were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Closure Time | To compare closure time and associated costs between these two methods of skin closure. | Posted | Mean | Standard Deviation | minutes | Baseline |
|
|
|
| Secondary | Closure Materials Cost | Per unit cost for suture and octylcyanoacrylate | Posted | Number | dollars | Baseline |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Octylcyanoacrylate | Skin incision closure with topic skin adhesive Octylcyanoacrylate Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate | 0 | 54 | 0 | 54 |
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