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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03159598
• Other study ID #: CASE5117
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients undergoing Abdominally-Based Breast Reconstruction
• Both unilateral or bilateral reconstruction is allowed
• Both delayed or immediate reconstruction is allowed

Exclusion Criteria:

• Diabetes
• BMI>30
• Active smokers.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of seroma development	Number of seromas which develop during the first 30 days after surgery.	Up to 30 days after surgery
Secondary	Difference in pain between patients with and without abdominal drains	Patients will be given a questionnaire pre-operatively and the same questionnaire post-operatively. The change in these questionnaires will be compared between groups	Up to 4 weeks after surgery
Secondary	Pain Medicine Utilization	Use of pain medicine after surgery between groups, as indicated by chart review	Up to 4 weeks after surgery
Secondary	Time to drain removal	Time from surgery to the removal of the drain for any reason, in patients who were given a drain	Up to 4 weeks after surgery