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OpenTrials
Completed

NCT Number: NCT03481140

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

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.

Completed

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Key information

Conditions

Deep Inferior Epigastric Perforator Flap Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TissuGlu Surgical Adhesive

Device

lysine-derived urethane adhesive

Primary outcomes

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

    Time frame: 6 weeks post-operatively

    number of interventions

Secondary outcomes

  1. total wound drainage

    Time frame: 6 weeks post-operatively

    drain volume + aspiration volume

  2. cumulative drain volume

    Time frame: 6 weeks post-operatively

    volume

  3. aspiration volume

    Time frame: 6 weeks post-operatively

    volume

  4. cumulative days of invasive treatment

    Time frame: 6 weeks post-operatively

    days with drains in + days in which an aspiration was performed

  5. days to drain removal

    Time frame: 6 weeks post-operatively

    days

Sponsors and collaborators

Lead sponsor

Cohera Medical, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2018
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.