62 Participants Needed

Pulsed Lavage for Breast Reconstruction

AC
Overseen ByAnn C Braswell, BS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

RJ

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

I am female.
I am having breast reconstruction with an implant right after mastectomy.
Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document

Exclusion Criteria

I am male.
I am having breast reconstruction with an implant after mastectomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mastectomy and breast reconstruction with or without pulsed lavage washout

1 day
1 visit (in-person)

Follow-up

Participants are monitored for post-op complications including surgical site infection, hematoma, seroma, and implant failure

3 months
Regular clinic visits

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
Trial Overview The study tests if pulsed lavage (a washing technique) during surgery can reduce complications like infections, fluid collections, and implant problems in immediate breast reconstruction after mastectomy.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Pulsed Lavage WashoutExperimental Treatment5 Interventions
Group II: No Pulsed LavageActive Control4 Interventions

Bilateral or unilateral mastectomy is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Mastectomy for:
🇪🇺
Approved in European Union as Mastectomy for:
🇨🇦
Approved in Canada as Mastectomy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Published Research Related to This Trial

The crescent mastopexy technique with augmentation for contralateral breast adjustment after unilateral reconstruction resulted in better aesthetic outcomes and symmetry compared to other mastopexy techniques, as evaluated by patient satisfaction and surgeon ratings.
This study involved 55 women who underwent breast reconstruction and symmetrization procedures, with results indicating that crescent mastopexy offers minimal scarring and improved cosmetic results, particularly for patients with mild breast ptosis.
Management of contralateral breast following mastectomy and breast reconstruction using a mirror adjustment with crescent mastopexy technique.Cogliandro, A., Brunetti, B., Barone, M., et al.[2022]
Breast cancer can still develop in women who have undergone prophylactic mastectomy, with 25 cases identified in a study of 2,708 women over a median follow-up of 22 years, highlighting the need for ongoing monitoring even after surgery.
The most common type of breast cancer that developed after prophylactic mastectomy was localized to the mastectomy site, which was often managed successfully with reoperation or local excision, resulting in a 5-year disease-free survival rate of 69% for those treated with curative intent.
Breast cancer after prophylactic mastectomy (bilateral or contralateral prophylactic mastectomy), a clinical entity: presentation, management, and outcomes.Mutter, RW., Frost, MH., Hoskin, TL., et al.[2015]
A novel intraoperative technique for bilateral breast reconstruction in patients undergoing unilateral postmastectomy radiation therapy (PMRT) was tested on 25 patients, resulting in improved symmetry between the irradiated and non-irradiated sides.
The technique involved adjusting the positioning of the acellular dermal matrix (ADM) and tissue expanders, leading to minimal adjustments needed during follow-up procedures, with 72% of patients not requiring any modifications to the inframammary fold after PMRT.
Technique to Promote Symmetry in 2-Staged Bilateral Breast Reconstruction in the Setting of Unilateral Postmastectomy Radiation.Roh, DS., Treiser, MD., Lafleur, EH., et al.[2017]

Citations

A Simple Technique Using Peri-Prosthetic Irrigation Improves ...The peri-prosthetic irrigation system is a simple, safe, and effective adjunct to conventional techniques in improving reconstruction salvage in IBR.
“Just Pulse it!” Introduction of a conservative implant ...In this preliminary study, we introduce a conservative protocol for pre-pectoral breast infection management through pulse lavage.
Irrigation Solutions in Wound Care and Breast SurgeryLow-pressure irrigation, typically delivered via gravity or a bulb syringe at ≤10 psi, is favored for its simplicity and minimal tissue trauma.
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/31367775/
Management of Capsular Contracture in Cases of Silicone ...PL irrigation of prosthesis pockets prior to open capsulotomy is a safe and effective treatment of CC with concurrent silicone leakage.
Pulsed Lavage for Breast ReconstructionIt can significantly reduce the risk of developing new breast cancer and offers options for achieving symmetry and aesthetic results after surgery. Techniques ...
A Simple Technique Using Peri-Prosthetic Irrigation ...The peri-prosthetic irrigation system is a simple, safe, and effective technique in improving implant/reconstruction salvage in IBR. PPI does not need any ...
Antimicrobial Irrigation and Technique during Breast ...Our results reveal significant variability regarding breast pocket irrigation techniques among ASPS members during cosmetic breast augmentation.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security