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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03481140

Enrollment

Registered

2018-03-29

Start date

2015-04-21

Completion date

2017-11-30

Last updated

2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Inferior Epigastric Perforator Flap Reconstruction

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.

Interventions

DEVICETissuGlu Surgical Adhesive

lysine-derived urethane adhesive

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026