Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial
Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Female
• Between 18 and 75 years of age, inclusive
• Undergoing implant-based breast reconstruction (unilateral or bilateral) with immediate expander at mastectomy
• Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Ann C Braswell, BS
acb98@uab.edu
256-595-3846
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-08
Participants
Target number of participants: 62
Treatments
Experimental: Pulsed Lavage Washout
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement and pulsed lavage washout.
Active_comparator: No Pulsed Lavage
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham