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

Decubitus Ulcer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482999
• Other study ID #: CLN-100-0025
• Status: Completed
• First received: March 22, 2018
• Last updated: March 28, 2018
• Start date: March 28, 2011
• Est. completion date: August 27, 2015

Study information

• Verified date: March 2018
• Source: Cohera Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 27, 2015
• Est. primary completion date: August 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• undergoing a procedure for decubitus repair

• be 22 years of age or older

Exclusion Criteria:

• expected flap size less than 5 sqcm

Related Conditions & MeSH terms

• Decubitus Ulcer
• Pressure Ulcer

Intervention

Device:
• TissuGlu Surgical Adhesive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cohera Medical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduce the post-operative duration of stay	duration	30 days
Primary	reduce the surgical revision rate	rate	30 days
Secondary	percent of patients requiring a revision	percent	30 days
Secondary	duration of wound drainage	duration	30 days