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

Deep Inferior Epigastric Perforator Flap Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481140
• Other study ID #: CLN-100-0024
• Status: Completed
• First received: March 22, 2018
• Last updated: March 27, 2018
• Start date: April 21, 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: March 2018
• Source: Cohera Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Inferior Epigastric Perforator Flap Reconstruction

Intervention

Device:
• TissuGlu Surgical Adhesive
lysine-derived urethane adhesive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cohera Medical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of post-operative clinical interventions related to wound fluid management at the donor site	number of interventions	6 weeks post-operatively
Secondary	total wound drainage	drain volume + aspiration volume	6 weeks post-operatively
Secondary	cumulative drain volume	volume	6 weeks post-operatively
Secondary	aspiration volume	volume	6 weeks post-operatively
Secondary	cumulative days of invasive treatment	days with drains in + days in which an aspiration was performed	6 weeks post-operatively
Secondary	days to drain removal	days	6 weeks post-operatively