CompletedNot Applicable

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

58 participantsStarted 2015-04-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: 6 weeks post-operatively

Trial details

NCT IDNCT03481140

SponsorCohera Medical, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-11-30

View on ClinicalTrials.gov More Deep Inferior Epigastric Perforator Flap Reconstruction trials