Breast ReconstructionNCT05585710
Pulsed Lavage in Implant-Based Breast Reconstruction
A study testing Pulsed Lavage Washout, Implant-based breast reconstruction and Bilateral or unilateral mastectomy in people with Breast Reconstruction, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Pulsed Lavage Washout, Implant-based breast reconstruction and Bilateral or unilateral mastectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Male
- < 18 years of age or > 75 years of age
- Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control 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.
Read the 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.
- Conditions
- Breast Reconstruction
- Being tested
- Pulsed Lavage Washout, Implant-based breast reconstruction, Bilateral or unilateral mastectomy, Tissue expander, Acellular dermal matrix
- Keywords
- breast reconstruction, implant-based breast reconstruction, pulsed lavage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Lavage WashoutOther
Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket
Implant-based breast reconstructionProcedure or surgery
Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
Bilateral or unilateral mastectomyProcedure or surgery
Standard of care
Tissue expanderDevice
Standard of care
Acellular dermal matrixOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Lavage Washout | Experimental | 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. Receives: Other: Pulsed Lavage Washout; Procedure: Implant-based breast reconstruction; Procedure: Bilateral or unilateral mastectomy; Device: Tissue expander; Other: Acellular dermal matrix |
| No Pulsed Lavage | Active comparator | 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. Receives: Procedure: Implant-based breast reconstruction; Procedure: Bilateral or unilateral mastectomy; Device: Tissue expander; Other: Acellular dermal matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-op Complications
unintended complications that occur post-surgically
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Mar 2024
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Why it stopped: Changes in personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Jobe Fix, University of Alabama at Birmingham
- Investigators
- Richard J Fix, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585710
- Sponsor's protocol ID
- IRB-300009900
- Other IDs
- UAB
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No