Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure
NCT ID: NCT03481140
Last Updated: 2018-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
58 participants
OBSERVATIONAL
2015-04-21
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Control
donor site DIEP flap breast reconstruction procedure with standard wound closure with drains
No interventions assigned to this group
TissuGlu Surgical Adhesive
donor site DIEP flap breast reconstruction procedure with standard wound closure with TissuGlu Surgical Adhesive and no drains
TissuGlu Surgical Adhesive
lysine-derived urethane adhesive
Interventions
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TissuGlu Surgical Adhesive
lysine-derived urethane adhesive
Eligibility Criteria
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Inclusion Criteria
* be in good general health (with no conditions that would, in the opinion of the surgeon, exclude them from a drain-free donor site approach)
* have a body mass index (BMI) \< 28
* have received a DIEP flap breast reconstruction procedure
Exclusion Criteria
* have a body mass index (BMI) \> 28
* taking active SSRI medication prescriptions
18 Years
ALL
No
Sponsors
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Cohera Medical, Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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CLN-100-0024
Identifier Type: -
Identifier Source: org_study_id
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