Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure
Completed
- Conditions
- Deep Inferior Epigastric Perforator Flap Reconstruction
- Interventions
- Device: TissuGlu Surgical Adhesive
- Registration Number
- NCT03481140
- Lead Sponsor
- Cohera Medical, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TissuGlu Surgical Adhesive TissuGlu Surgical Adhesive donor site DIEP flap breast reconstruction procedure with standard wound closure with TissuGlu Surgical Adhesive and no drains
- Primary Outcome Measures
Name Time Method number of post-operative clinical interventions related to wound fluid management at the donor site 6 weeks post-operatively number of interventions
- Secondary Outcome Measures
Name Time Method total wound drainage 6 weeks post-operatively drain volume + aspiration volume
cumulative drain volume 6 weeks post-operatively volume
days to drain removal 6 weeks post-operatively days
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