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Trial Outcomes & Findings for Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets (NCT NCT00674128)

NCT ID: NCT00674128

Last Updated: 2010-12-29

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

Within 3 months after surgery.

Results posted on

2010-12-29

Participant Flow

Patients were recruited sequentially at a tertiary care medical center between 2 June 2008 and 19 February 2009.

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.

Participant milestones

Participant milestones
Measure
Adhesive
Cyanoacrylate tissue adhesive.
Suture
Polyglactin 910 suture.
Overall Study
STARTED
50
44
Overall Study
COMPLETED
25
21
Overall Study
NOT COMPLETED
25
23

Reasons for withdrawal

Reasons for withdrawal
Measure
Adhesive
Cyanoacrylate tissue adhesive.
Suture
Polyglactin 910 suture.
Overall Study
Withdrawal by Subject
25
23

Baseline Characteristics

Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Adhesive
n=50 Participants
Cyanoacrylate tissue adhesive.
Suture
n=44 Participants
Polyglactin 910 suture.
Total
n=94 Participants
Total of all reporting groups
Age Continuous
77 years
STANDARD_DEVIATION 10 • n=5 Participants
77.6 years
STANDARD_DEVIATION 9.2 • n=7 Participants
77 years
STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
13 Participants
n=7 Participants
29 Participants
n=5 Participants
Sex: Female, Male
Male
34 Participants
n=5 Participants
31 Participants
n=7 Participants
65 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Within 3 months after surgery.

Outcome measures

Outcome measures
Measure
Adhesive
n=25 Participants
Cyanoacrylate tissue adhesive.
Suture
n=21 Participants
Polyglactin 910 suture.
Reported Here Are the Number of Participants With Devices That Developed Infection
2 participants
1 participants

Adverse Events

Adhesive

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Suture

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Adhesive
n=25 participants at risk
Cyanoacrylate tissue adhesive.
Suture
n=21 participants at risk
Polyglactin 910 suture
Infections and infestations
Device Pocket Infection
8.0%
2/25 • 3 months
No adverse event data were collected other than infection.
4.8%
1/21 • 3 months
No adverse event data were collected other than infection.

Additional Information

Gregory Altemose MD

Mayo Clinic

Phone: 480-301-8000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place