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Slow accrual.
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The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adhesive | Experimental | Cyanoacrylate tissue adhesive. |
|
| Suture | Active Comparator | Polyglactin 910 suture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyanoacrylate tissue adhesive (Dermabond) | Device | Skin closure will be performed with cyanoacrylate tissue adhesive. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reported Here Are the Number of Participants With Devices That Developed Infection | Within 3 months after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Altemose, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
33 patients did not meet inclusion criteria. 16 eligible patients did not consent. 103 patients were eligible and consented. 55 were assigned to Adhesive and 48 to Suture. The procedure was aborted for 5 patients in the Adhesive group and 4 patients in the Suture group.
Patients were recruited sequentially at a tertiary care medical center between 2 June 2008 and 19 February 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adhesive | Cyanoacrylate tissue adhesive. |
| FG001 | Suture | Polyglactin 910 suture. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adhesive | Cyanoacrylate tissue adhesive. |
| BG001 | Suture | Polyglactin 910 suture. |
| 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 | Reported Here Are the Number of Participants With Devices That Developed Infection | Posted | Number | participants | Within 3 months after surgery. |
|
|
3 months
No adverse event data were collected other than infection.
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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 | Adhesive | Cyanoacrylate tissue adhesive. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Pocket Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Altemose MD | Mayo Clinic | 480-301-8000 | altemose.gregory@mayo.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Polyglactin 910 suture (Vicryl) | Device | Skin closure will be performed with polyglactin 910 suture. |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 0 |
| 2 |
| 25 |
| EG001 | Suture | Polyglactin 910 suture | 0 | 0 | 1 | 21 |
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