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RECRUITING
NCT05585710
NA

Pulsed Lavage in Implant-Based Breast Reconstruction

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Official title: Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2024-03-01

Completion Date

2026-08

Last Updated

2025-04-10

Healthy Volunteers

No

Interventions

OTHER

Pulsed Lavage Washout

Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket

PROCEDURE

Implant-based breast reconstruction

Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket

PROCEDURE

Bilateral or unilateral mastectomy

Standard of care

DEVICE

Tissue expander

Standard of care

OTHER

Acellular dermal matrix

Standard of care

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States