Cardiovascular Disease
Conditions
Keywords
pacemaker, cardioverter-defibrillator, ICD, cardiac resynchronization device, cyanoacrylate, suture, Dermabond, Vicryl
Brief summary
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.
Interventions
DEVICECyanoacrylate tissue adhesive (Dermabond)
Skin closure will be performed with cyanoacrylate tissue adhesive.
DEVICEPolyglactin 910 suture (Vicryl)
Skin closure will be performed with polyglactin 910 suture.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for implantation of a pacemaker or ICD in the deltopectoral region at Mayo Clinic Hospital in Phoenix.
Exclusion criteria
* Allergy to one of the closure materials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reported Here Are the Number of Participants With Devices That Developed Infection | Within 3 months after surgery. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited sequentially at a tertiary care medical center between 2 June 2008 and 19 February 2009.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Adhesive Cyanoacrylate tissue adhesive. | 50 |
| Suture Polyglactin 910 suture. | 44 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 25 | 23 |
Baseline characteristics
| Characteristic | Adhesive | Suture | Total |
|---|---|---|---|
| Age Continuous | 77 years STANDARD_DEVIATION 10 | 77.6 years STANDARD_DEVIATION 9.2 | 77 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 34 Participants | 31 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 25 | 1 / 21 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Reported Here Are the Number of Participants With Devices That Developed Infection
Time frame: Within 3 months after surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adhesive | Reported Here Are the Number of Participants With Devices That Developed Infection | 2 participants |
| Suture | Reported Here Are the Number of Participants With Devices That Developed Infection | 1 participants |