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

Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Comparing SWC With Drains to SWC With TissuGlu® and no Drains in a Donor Site DIEP Flap Breast Reconstruction Procedure in 58 Patients

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.

Study Overview

• Status: Completed
• Conditions: Deep Inferior Epigastric Perforator Flap Reconstruction
• Intervention / Treatment: Device: TissuGlu Surgical Adhesive

• Study Type: Observational
• Enrollment (Actual): 58

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; lysine-derived urethane adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
total wound drainage	drain volume + aspiration volume	6 weeks post-operatively
cumulative drain volume	volume	6 weeks post-operatively
aspiration volume	volume	6 weeks post-operatively
cumulative days of invasive treatment	days with drains in + days in which an aspiration was performed	6 weeks post-operatively
days to drain removal	days	6 weeks post-operatively

Collaborators and Investigators

• Sponsor: Cohera Medical, Inc.

Study record dates

Study Major Dates

• Study Start: April 21, 2015
• Primary Completion (ACTUAL): November 30, 2017
• Study Completion (ACTUAL): November 30, 2017

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (ACTUAL): March 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CLN-100-0024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No