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

Cohera Medical

Status: Completed

Conditions: Deep Inferior Epigastric Perforator Flap Reconstruction

Treatments: Device: TissuGlu Surgical Adhesive

Study type: Observational

Funder types: Industry

Identifiers

NCT03481140

CLN-100-0024

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

58 participants in 2 patient groups

Control

Description:

donor site DIEP flap breast reconstruction procedure with standard wound closure with drains

TissuGlu Surgical Adhesive

Description:

donor site DIEP flap breast reconstruction procedure with standard wound closure with TissuGlu Surgical Adhesive and no drains

Treatment:

Device: TissuGlu Surgical Adhesive