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
Qualifiers
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
Treatments tested in this trial
- Pulsed Lavage Washout
- Implant-based breast reconstruction
- Bilateral or unilateral mastectomy
- Tissue expander
- Acellular dermal matrix
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov