Pulsed Lavage in Implant-Based Breast Reconstruction
ConditionBreast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Pulsed Lavage Washout
Other interventionUse of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket
Implant-based breast reconstruction
Procedure/SurgeryStandard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
Bilateral or unilateral mastectomy
Procedure/SurgeryStandard of care
Tissue expander
DeviceStandard of care
Acellular dermal matrix
Other interventionStandard of care
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Pulsed Lavage WashoutExperimental treatment 5 interventions
Group B: No Pulsed LavageActive comparator 4 interventions
Trial outcomes
Primary outcomes
1
Post-op Complications
unintended complications that occur post-surgically
Time frame
up to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov