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Pulsed Lavage for Breast Reconstruction

N/A
Recruiting
Led By Prasanth Patcha, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 18 and 75 years of age, inclusive
Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study Summary

This trial will study if pulsed lavage reduces post-op complications in breast reconstruction patients. Outcomes include SSI, hematoma, seroma, & implant failure.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include issues at the surgical site such as infection, hematoma (blood pooling), seroma (fluid buildup), or failure of the breast implant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I am female.
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I am having breast reconstruction with an implant right after mastectomy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-op Complications

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pulsed Lavage WashoutExperimental Treatment5 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 LavageActive Control4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tissue expander
2017
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,580 Previous Clinical Trials
2,275,933 Total Patients Enrolled
Prasanth Patcha, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Richard J Fix, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Bilateral or unilateral mastectomy Clinical Trial Eligibility Overview. Trial Name: NCT05585710 — N/A
Breast Reconstruction Research Study Groups: Pulsed Lavage Washout, No Pulsed Lavage
Breast Reconstruction Clinical Trial 2023: Bilateral or unilateral mastectomy Highlights & Side Effects. Trial Name: NCT05585710 — N/A
Bilateral or unilateral mastectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05585710 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial admit participants under 35 years old?

"Per the conditions of this trial, only persons aged 18 to 75 are eligible for recruitment."

Answered by AI

Is recruitment ongoing for this research endeavor?

"Reported on clinicaltrials.gov, this medical experiment is no longer accruing participants. The trial appeared online in January of 2023 and was most recently updated in November 2022. Although not recruiting any new patients at the moment, there are 23 other trials actively taking partakers now."

Answered by AI

To what demographic does this study extend its invitation?

"This clinical trial is inviting 62 female applicants aged 18 to 75 who are undergoing implant-based breast reconstruction with an immediate expander at mastectomy. Additionally, volunteers must be willing and able to sign a written informed consent document that has been approved by the Institutional Review Board."

Answered by AI
~41 spots leftby Aug 2025