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Pulsed Lavage in Implant-Based Breast Reconstruction

NCT05585710 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Breast Reconstruction

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

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Richard J Fix, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2027-03-31
Completion
2027-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585710 on ClinicalTrials.gov