Pulsed Lavage for Breast Reconstruction

Overseen By Ann C Braswell, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Male, Delayed expander, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

62 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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

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?

Group I: Pulsed Lavage Washout Experimental Treatment 5 Interventions

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.

Group II: No Pulsed Lavage Active Control 4 Interventions

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.

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

Approved in United States as Mastectomy for:

• Breast cancer
• High-risk breast cancer prevention
• BRCA mutation carriers
• Family history of breast cancer

Approved in European Union as Mastectomy for:

• Breast cancer
• High-risk breast cancer prevention
• BRCA mutation carriers
• Family history of breast cancer

Approved in Canada as Mastectomy for:

• Breast cancer
• High-risk breast cancer prevention
• BRCA mutation carriers
• Family history of breast cancer

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Between 1998 and 2007, there was a significant increase in the use of contralateral prophylactic mastectomy (CPM) for unilateral breast cancer, rising from 6.5% to 16.1%.

Women opting for CPM were generally younger (average age 47.8 vs. 55.1 years), more educated, and had a higher likelihood of a family history of cancer compared to those who chose unilateral mastectomy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contralateral prophylactic mastectomy for unilateral breast cancer: an increasing trend at a single institution. Jones, NB., Wilson, J., Kotur, L., et al.[2022]

In a study of 20,501 women with unilateral breast cancer, those who underwent contralateral prophylactic mastectomy (CPM) experienced longer hospital stays and higher transfusion rates compared to those who had unilateral mastectomy (UM).

While CPM was linked to increased reoperation rates and wound disruptions, it did not lead to a higher incidence of medical complications, suggesting that while there are some added surgical risks, overall medical safety remains comparable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Contralateral Prophylactic Mastectomy on Perioperative Complications in Women Undergoing Immediate Breast Reconstruction: A NSQIP Analysis. Silva, AK., Lapin, B., Yao, KA., et al.[2022]

The 'two-stage, single-operation' approach for combined augmentation and mastopexy in patients with unilateral breast reconstruction resulted in a 'very good to excellent' aesthetic outcome in 69% of cases, with no patients requiring revisional surgery for issues like nipple malpositioning.

This technique allows for effective aesthetic results while still enabling oncologic follow-up through mammography, particularly benefiting patients with grade I or II ptosis and good-quality skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demystifying trans-axillary augmentation/periareolar mastopexy: a novel, two-stage, single-operation approach to management of the contralateral breast in implant reconstruction. Kropf, N., Cordeiro, CN., McCarthy, CM., et al.[2011]

In a study of 62 patients undergoing bilateral mastectomy with immediate reconstruction, the overall complication rate was higher on the therapeutic side (23.9%) compared to the prophylactic side (16.5%).

Infections were the most common complication, with all infections on the prophylactic side successfully treated with IV antibiotics, while a significant portion (35.7%) of infections on the therapeutic side required explantation despite treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral immediate two-stage breast reconstruction in patients with unilateral breast cancer: Outcomes analysis and risk assessment. Ozturk, CN., Ozturk, C., Soucise, A., et al.[2021]

In a study of 4,219 breast cancer patients, those undergoing bilateral mastectomy (BM) had a significantly higher wound complication rate (5.8%) compared to those with unilateral mastectomy (UM) (2.9%), indicating increased risk associated with BM.

The overall 30-day complication rate was also higher in the BM group (7.6%) compared to the UM group (4.2%), suggesting that women considering contralateral prophylactic mastectomy should be informed about these increased risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased postoperative complications in bilateral mastectomy patients compared to unilateral mastectomy: an analysis of the NSQIP database. Osman, F., Saleh, F., Jackson, TD., et al.[2022]

In a study of 160 women undergoing immediate bilateral breast reconstruction after unilateral breast cancer, complications were significantly more common in the cancerous breast (20.6%) compared to the noncancerous breast (4.4%).

While radiation exposure increased complication rates on the cancerous side, even patients without radiation exposure experienced more complications on the cancer side, indicating that the cancerous breast is at a higher risk for complications overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is It Worth the Risk? Contralateral Prophylactic Mastectomy With Immediate Bilateral Breast Reconstruction. Chadab, TM., Bernstein, JL., Lifrieri, A., et al.[2023]

From 1991 to 2013, the rate of bilateral mastectomy (BM) in women with unilateral breast cancer (UBC) in Ontario increased more than sixfold, from 4% to 25%, indicating a significant trend towards more aggressive surgical options despite a lack of evidence for survival benefits.

Factors associated with a higher likelihood of undergoing BM included being younger, having a higher income, living in rural areas, being diagnosed at an earlier stage of breast cancer, having lobular histology, and access to reconstruction and teaching hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canada follows the US in the rise of bilateral mastectomies for unilateral breast cancer: a 23-year population cohort study. Findlay-Shirras, L., Lima, I., Smith, G., et al.[2021]

A study of 621 women who underwent contralateral prophylactic mastectomy (CPM) found that 83% reported satisfaction with the procedure, and 92% would choose CPM again after an average of 20 years.

Women who opted for reconstruction experienced lower satisfaction rates, particularly if they required unplanned reoperations, highlighting the importance of considering potential complications when making treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of reconstruction and reoperation on long-term patient-reported satisfaction after contralateral prophylactic mastectomy. Boughey, JC., Hoskin, TL., Hartmann, LC., et al.[2022]

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pmc.ncbi.nlm.nih.gov

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The peri-prosthetic irrigation system is a simple, safe, and effective adjunct to conventional techniques in improving reconstruction salvage in IBR.

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“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.

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mdpi.com

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Irrigation Solutions in Wound Care and Breast Surgery

Low-pressure irrigation, typically delivered via gravity or a bulb syringe at ≤10 psi, is favored for its simplicity and minimal tissue trauma.

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PL irrigation of prosthesis pockets prior to open capsulotomy is a safe and effective treatment of CC with concurrent silicone leakage.

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withpower.com/trial/phase-breast-reconstruction-9-2022-8798a

Pulsed Lavage for Breast Reconstruction

It can significantly reduce the risk of developing new breast cancer and offers options for achieving symmetry and aesthetic results after surgery. Techniques ...

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The peri-prosthetic irrigation system is a simple, safe, and effective technique in improving implant/reconstruction salvage in IBR. PPI does not need any ...

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pmc.ncbi.nlm.nih.gov

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Antimicrobial Irrigation and Technique during Breast ...

Our results reveal significant variability regarding breast pocket irrigation techniques among ASPS members during cosmetic breast augmentation.