Breast Reconstruction
Conditions
Keywords
breast reconstruction, implant-based breast reconstruction, pulsed lavage
Brief 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.
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
OTHERPulsed Lavage Washout
Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket
PROCEDUREImplant-based breast reconstruction
Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
PROCEDUREBilateral or unilateral mastectomy
Standard of care
DEVICETissue expander
Standard of care
Standard of care
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Pulsed Lavage is a surgical technique that cannot be masked from the investigators performing the operation.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-op Complications | up to 3 months | unintended complications that occur post-surgically |
Countries
United States
Contacts
CONTACTAnn C Braswell, BS
PRINCIPAL_INVESTIGATORRichard J Fix, MD
University of Alabama at Birmingham
Outcome results
None listed