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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-21

Study Completion Date

2017-11-30

Brief Summary

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To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator (DIEP) flap reconstruction.

Detailed Description

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Conditions

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Deep Inferior Epigastric Perforator Flap Reconstruction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type DEVICE

lysine-derived urethane adhesive

Interventions

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TissuGlu Surgical Adhesive

lysine-derived urethane adhesive

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* be 18 years of age or older
* 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

* current smoker
* have a body mass index (BMI) \> 28
* taking active SSRI medication prescriptions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cohera Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CLN-100-0024

Identifier Type: -

Identifier Source: org_study_id

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