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

Completed

• Conditions: Decubitus Ulcer
• Interventions: Device: TissuGlu Surgical Adhesive

• Registration Number: NCT03482999
• Lead Sponsor: Cohera Medical, Inc.

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.

Study Timeline

• Study Start: 2011-03-28
• Primary Completion: 2015-08-27
• Study Completion: 2015-08-27
• Status Verified: 2018-03
• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-03-28
• Last Update Submitted: 2018-03-28
• Study First Posted: 2018-03-29
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TissuGlu Surgical Adhesive	TissuGlu Surgical Adhesive	TissuGlu was used for approximation and adhesion of the flaps in conjunction with drains

Primary Outcome Measures

Name	Time	Method
reduce the post-operative duration of stay	30 days	duration
reduce the surgical revision rate	30 days	rate

Secondary Outcome Measures

Name	Time	Method
duration of wound drainage	30 days	duration
percent of patients requiring a revision	30 days	percent