NCT03159598

Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive

Drain-Less Abdominally Based Breast Reconstruction Using a Novel Lysine-Derived Urethane Adhesive (TissueGlu, Cohera Medical)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Drains are routinely utilized in breast reconstruction when using abdominal tissue of the patient to remove fluid buildup while the body heals after surgery. However, drains are associated with patient discomfort, anxiety, decreased mobility, increased hospital stays and outpatient visits. Drains can also serve as a site of origin for infection as the system is not completely closed, and infectious organisms could theoretically use the drain as point of entry. This proposed study investigates a potential novel mechanism to prevent the development of seromas (pockets of clear fluid which can develop after surgery) in patients who undergo breast reconstruction with their own abdominal tissue. By eliminating the required use of a drain, the study team expects patients to have less pain and use less pain medication, as well as more satisfaction with their overall surgical experience.

Detailed description

Objectives: 1. Establish the safety of a lysine-derived urethane adhesive (TissuGlu, Cohera Medical) in patients undergoing autologous abdominal-based breast reconstruction. This will be assessed via analyzing complication profiles of patients post-operatively. The primary endpoints are rate of seroma development, need for seroma drainage and time to drain removal (if in drain group). 2. Determine if there is a difference in pain and other quality of life measures when comparing patients who do and do not have abdominal drains. This will be assessed via pain medicine utilization and by delivering a targeted survey pre-operatively, as well as at post-operative day three and four weeks. Study Design: Patients will be randomized to one of three arms: 1) Traditional closed-suction drains, 2) TissuGlu with closed-suction drains and 3) TissuGlu without closed-suction drains.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Tissue Glu	Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied. Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.
DEVICE	Drain	Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
OTHER	Questionnaires	Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-02-01
• Completion: 2021-09-01
• First posted: 2017-05-18
• Last updated: 2020-11-24

Regulatory

• FDA-regulated device study