Pulsed Lavage in Implant-Based Breast Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Reconstruction

Intervention / Treatment
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* Other: Pulsed Lavage Washout
* Procedure: Implant-based breast reconstruction
* Procedure: Bilateral or unilateral mastectomy
* Device: Tissue expander
* Other: Acellular dermal matrix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two cohorts will be established. One cohort will include patients who undergo pulsed lavage to wash out the mastectomy pocket. The other cohort will include patients who do not receive pulsed lavage.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed Lavage Washout<br>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. | Other: Pulsed Lavage Washout<br>* Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket<br>Procedure: Implant-based breast reconstruction<br>* Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket<br>Procedure: Bilateral or unilateral mastectomy<br>* Standard of care<br>Device: Tissue expander<br>* Standard of care<br>Other: Acellular dermal matrix<br>* Standard of care<br>|
| Active Comparator: No Pulsed Lavage<br>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. | Procedure: Implant-based breast reconstruction<br>* Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket<br>Procedure: Bilateral or unilateral mastectomy<br>* Standard of care<br>Device: Tissue expander<br>* Standard of care<br>Other: Acellular dermal matrix<br>* Standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-op Complications | unintended complications that occur post-surgically | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reconstruction, implant-based breast reconstruction, pulsed lavage