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NCT Number: NCT05585710

Pulsed Lavage in Implant-Based Breast Reconstruction

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.

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Key information

Conditions

Breast Reconstruction

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Ann C Braswell, BS

CONTACT

[email protected]

2565953846

Richard J Fix, MD

PRINCIPAL_INVESTIGATOR

About this study

After being informed of the study including potential risks and benefits, all patients giving consent who meet eligibility requirements will undergo randomization into either the pulsed lavage arm (receive mastectomy pocket wash out using pulsed lavage) or the no pulsed lavage arm (pulsed lavage will not be used). Randomization will occur using a random number generator with even numbers resulting in a pulsed lavage washout and odd numbers resulting in no pulsed lavage washout.

The patients will be followed in clinic for a maximum of 3 months to evaluate the surgical site. The two cohorts will be compared at the end of the study to determine whether there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Post-op Complications

    Time frame: up to 3 months

    unintended complications that occur post-surgically

Study contacts

Contact information is provided by the study sponsor or research team.

Ann C Braswell, BS

CONTACT

[email protected]

256-595-3846

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 19, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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