Pulsed Lavage in Implant-Based Breast Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulsed Lavage Washout, Implant-based breast reconstruction, Bilateral or unilateral mastectomy, Tissue expander.
- Who it may be relevant to
- Registry conditions: Breast Reconstruction. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial
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.
Detailed 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.
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
Primary outcome measures
- Post-op Complications [Time frame: up to 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT05585710 · IRB-300009900 · UAB