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

March 28, 2018 updated by: Cohera Medical, Inc.

Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Assessing a Lysine-Derived Urethane Adhesive (TissuGlu® Surgical Adhesive) in Flap Surgery for Decubitus Repair

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population included patients undergoing flap surgery for decubitus repair between March 2011 and July 2015. In October 2013, the investigator converted to the use of TissuGlu® Surgical Adhesive in conjunction with surgical drains as their standard of care for flap surgery for decubitus repair. The analysis was performed retrospectively on two consecutive cohort groups.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • expected flap size less than 5 sqcm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Standard Wound Closure with drains
TissuGlu Surgical Adhesive
TissuGlu was used for approximation and adhesion of the flaps in conjunction with drains
Device: TissuGlu Surgical Adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduce the post-operative duration of stay
Time Frame: 30 days
duration
30 days
reduce the surgical revision rate
Time Frame: 30 days
rate
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percent of patients requiring a revision
Time Frame: 30 days
percent
30 days
duration of wound drainage
Time Frame: 30 days
duration
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cohera Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2011

Primary Completion (Actual)

August 27, 2015

Study Completion (Actual)

August 27, 2015

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-100-0025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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