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

NCT03481140 | Completed FDA Device

• 1 other identifier: CLN-100-0024
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deep Inferior Epigastric Perforator Flap Reconstruction

Outcome Measures

Primary Outcomes (1)

• number of post-operative clinical interventions related to wound fluid management at the donor site

  number of interventions

  6 weeks post-operatively

Secondary Outcomes (5)

• total wound drainage

  6 weeks post-operatively

• cumulative drain volume

  6 weeks post-operatively

• aspiration volume

  6 weeks post-operatively

• cumulative days of invasive treatment

  6 weeks post-operatively

• days to drain removal

  6 weeks post-operatively

Study Arms (2)

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

TissuGlu Surgical Adhesive DEVICE

lysine-derived urethane adhesive

TissuGlu Surgical Adhesive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cohera Medical, Inc.: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: April 21, 2015
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03