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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03482999

Enrollment

Registered

2018-03-29

Start date

2011-03-28

Completion date

2015-08-27

Last updated

2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decubitus Ulcer

Brief summary

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

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.

Interventions

DEVICETissuGlu Surgical Adhesive

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* expected flap size less than 5 sqcm

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
percent of patients requiring a revision	30 days	percent
duration of wound drainage	30 days	duration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026