Case Series Assessing TissuGlu® Surgical Adhesive in Flap Surgery for Decubitus Repair

NCT ID: NCT03482999

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-28

Study Completion Date

2015-08-27

Brief Summary

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To evaluate the impact of a high strength lysine-based adhesive (TissuGlu® Surgical Adhesive) on complications and revision rates in large flap surgery for decubitus repair.

Detailed Description

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A total of 50 subjects undergoing flap surgery for decubitus repair at the Clinic for Plastic and Aesthetic Surgery, Hand Surgery, St. Joseph's Hospital in Hagen, Germany were included in a post-market investigator initiated, retrospective observational series study.

Conditions

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Decubitus Ulcer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control

Standard Wound Closure with drains

No interventions assigned to this group

TissuGlu Surgical Adhesive

TissuGlu was used for approximation and adhesion of the flaps in conjunction with drains

TissuGlu Surgical Adhesive

Intervention Type DEVICE

Interventions

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TissuGlu Surgical Adhesive

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* undergoing a procedure for decubitus repair
* be 22 years of age or older

Exclusion Criteria

* expected flap size less than 5 sqcm
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-100-0025

Identifier Type: -

Identifier Source: org_study_id

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