Pulsed Lavage in Implant-Based Breast Reconstruction

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Breast Reconstruction

Treatments: Procedure: Bilateral or unilateral mastectomy; Other: Acellular dermal matrix; Procedure: Implant-based breast reconstruction; Device: Tissue expander; Other: Pulsed Lavage Washout

Study type: Interventional

Funder types: Other

Identifiers

NCT05585710

IRB-300009900

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Pulsed Lavage Washout

Experimental group

Description:

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.

Treatment:

Other: Pulsed Lavage Washout

Device: Tissue expander

Procedure: Implant-based breast reconstruction

Other: Acellular dermal matrix

Procedure: Bilateral or unilateral mastectomy

No Pulsed Lavage

Active Comparator group

Description:

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.

Treatment:

Device: Tissue expander

Procedure: Implant-based breast reconstruction

Other: Acellular dermal matrix

Procedure: Bilateral or unilateral mastectomy