Case Series Assessing TissuGlu® Surgical Adhesive in Flap... | NCT03482999

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

NCT03482999

Sponsor

Cohera Medical, Inc.

Status

Completed

Last Update Posted

Mar 29, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Decubitus Ulcer

Interventions

TissuGlu Surgical Adhesive

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2011Actual

Primary Completion Date

Aug 27, 2015Actual

Completion Date

Aug 27, 2015Actual

First Submitted Date

Mar 22, 2018

First Submission Date that Met QC Criteria

Mar 28, 2018

First Posted Date

Mar 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2018

Last Update Posted Date

Mar 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		Standard Wound Closure with drains
TissuGlu Surgical Adhesive		TissuGlu was used for approximation and adhesion of the flaps in conjunction with drains	Device: TissuGlu Surgical Adhesive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TissuGlu Surgical Adhesive	Device		TissuGlu Surgical Adhesive

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

expected flap size less than 5 sqcm

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study population included patients undergoing flap surgery for decubitus repair between March 2011 and July 2015. In October 2013, the investigator converted to the use of TissuGlu® Surgical Adhesive in conjunction with surgical drains as their standard of care for flap surgery for decubitus repair. The analysis was performed retrospectively on two consecutive cohort groups.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided