Case Series Assessing 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.

Completed

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Key information

Conditions

Decubitus Ulcer Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

expected flap size less than 5 sqcm

Treatment and study plan

TissuGlu Surgical Adhesive

Device

Primary outcomes

reduce the post-operative duration of stay

Time frame: 30 days

duration
reduce the surgical revision rate

Time frame: 30 days

rate

Secondary outcomes

percent of patients requiring a revision

Time frame: 30 days

percent
duration of wound drainage

Time frame: 30 days

duration

Sponsors and collaborators

Lead sponsor

Cohera Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Mar 29, 2018
Registry last updated: Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed