Pulsed Lavage for Breast Reconstruction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether using pulsed lavage (a high-pressure water wash) to clean the mastectomy pocket during breast reconstruction surgery can reduce complications such as infections, bleeding, and implant issues. Participants will undergo breast reconstruction with tissue expanders, with some receiving the pulsed lavage treatment and others not. Women undergoing immediate implant-based breast reconstruction after a mastectomy might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical outcomes.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What prior data suggests that pulsed lavage is safe for breast reconstruction?
Research has shown that pulsed lavage washout is a safe method used in breast reconstruction surgery. Studies have found that this technique effectively cleans the surgical area with minimal risk. For example, it safely cleans around implants, helping to prevent problems like infections. Pulsed lavage uses gentle water pressure, reducing the risk of tissue damage. Overall, evidence suggests that pulsed lavage is well-tolerated and poses little risk to patients.12345
Why are researchers excited about this trial?
Researchers are excited about using pulsed lavage washout in breast reconstruction because it offers a unique way to clean the surgical area during the procedure. Unlike standard methods, which might involve simple rinsing, pulsed lavage uses a pressurized stream of fluid to thoroughly irrigate and remove debris and bacteria. This technique could potentially reduce the risk of infection and improve healing, which is a significant advancement over current options. By enhancing the cleanliness of the surgical site, pulsed lavage may lead to better outcomes for patients undergoing mastectomies and reconstruction.
What evidence suggests that pulsed lavage is effective for reducing post-op complications in breast reconstruction?
Research has shown that pulsed lavage, which uses a pressurized fluid stream to clean surgical areas, may improve outcomes in breast reconstruction. In this trial, one group of participants will receive pulsed lavage during surgery. Studies have found that this method can help save breast implants if complications arise. It effectively cleans the surgical site, reducing infection risk. Additionally, pulsed lavage has successfully treated infections around breast implants, suggesting it helps maintain cleanliness and supports healing. These findings offer promising evidence that pulsed lavage could benefit breast reconstruction procedures.13467
Who Is on the Research Team?
Richard J Fix, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for women aged 18-75 who are having breast reconstruction with a tissue expander right after mastectomy. They must understand and sign consent. It's not for those getting delayed reconstruction or men.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo mastectomy and breast reconstruction with or without pulsed lavage washout
Follow-up
Participants are monitored for post-op complications including surgical site infection, hematoma, seroma, and implant failure
What Are the Treatments Tested in This Trial?
Interventions
- Bilateral or unilateral mastectomy
- Current Standard of Care
- Implant-based breast reconstruction
- Pulse Lavage Washout
- Tissue expander
Bilateral or unilateral mastectomy is already approved in United States, European Union, Canada for the following indications:
- Breast cancer
- High-risk breast cancer prevention
- BRCA mutation carriers
- Family history of breast cancer
- Breast cancer
- High-risk breast cancer prevention
- BRCA mutation carriers
- Family history of breast cancer
- Breast cancer
- High-risk breast cancer prevention
- BRCA mutation carriers
- Family history of breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor