Pulsed Lavage in Implant-Based Breast Reconstruction

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05585710
Status
Recruiting
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Conditions

  • Breast Reconstruction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pulsed Lavage Washout — OTHER
    Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket
  • Implant-based breast reconstruction — PROCEDURE
    Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
  • Bilateral or unilateral mastectomy — PROCEDURE
    Standard of care
  • Tissue expander — DEVICE
    Standard of care
  • Acellular dermal matrix — OTHER
    Standard of care

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Post-op Complications [ Time Frame: up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Ann C Braswell, BS
[email protected]
2565953846
Richard J Fix, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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