Trials / Completed
CompletedNCT03482999
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Cohera Medical, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TissuGlu Surgical Adhesive |
Timeline
- Start date
- 2011-03-28
- Primary completion
- 2015-08-27
- Completion
- 2015-08-27
- First posted
- 2018-03-29
- Last updated
- 2018-03-29
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03482999. Inclusion in this directory is not an endorsement.