Pulsed Lavage in Implant-Based Breast Reconstruction

Description

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.

Conditions

Breast Reconstruction

Study Overview

Study Details

Study overview

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.

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

Pulsed Lavage in Implant-Based Breast Reconstruction

Condition
Breast Reconstruction
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Male
  • * \< 18 years of age or \> 75 years of age
  • * Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Richard J Fix, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2025-08