Case Series Comparing Drains to TissuGlu® in a Donor Site... | NCT03481140

Studies
Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure

NCT03481140

Sponsor

Cohera Medical, Inc.

Status

Completed

Last Update Posted

Mar 29, 2018Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Deep Inferior Epigastric Perforator Flap Reconstruction

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

Apr 21, 2015

Primary Completion Date

Nov 30, 2017Actual

Completion Date

Nov 30, 2017Actual

First Submitted Date

Mar 22, 2018

First Submission Date that Met QC Criteria

Mar 27, 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 27, 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 safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator (DIEP) flap reconstruction.

Detailed Description

Not provided

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

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		donor site DIEP flap breast reconstruction procedure with standard wound closure with drains
TissuGlu Surgical Adhesive		donor site DIEP flap breast reconstruction procedure with standard wound closure with TissuGlu Surgical Adhesive and no drains	Device: TissuGlu Surgical Adhesive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TissuGlu Surgical Adhesive	Device	lysine-derived urethane adhesive	TissuGlu Surgical Adhesive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of post-operative clinical interventions related to wound fluid management at the donor site	number of interventions	6 weeks post-operatively

Secondary Outcomes

Measure	Description	Time Frame
total wound drainage	drain volume + aspiration volume	6 weeks post-operatively
cumulative drain volume	volume	6 weeks post-operatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

be 18 years of age or older
be in good general health (with no conditions that would, in the opinion of the surgeon, exclude them from a drain-free donor site approach)
have a body mass index (BMI) < 28
have received a DIEP flap breast reconstruction procedure

Exclusion Criteria:

current smoker
have a body mass index (BMI) > 28
taking active SSRI medication prescriptions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing a DIEP flap breast reconstruction at the Sana Klinik in Düsseldorf, Germany.

Sampling Method

Non-Probability Sample