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Pulsed Lavage for Breast Reconstruction
Birmingham, AL
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if pulsed lavage reduces post-op complications in breast reconstruction patients. Outcomes include SSI, hematoma, seroma, & implant failure.
See full description
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-op Complications
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Closest Location:University of Alabama at Birmingham· Birmingham, AL· 494 miles
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,672 Previous Clinical Trials
2,457,153 Total Patients Enrolled
Prasanth Patcha, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Richard J Fix, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old.I am male.I am female.I am having breast reconstruction with an implant right after mastectomy.I am having breast reconstruction with an implant after mastectomy.I am younger than 18 or older than 75.
Research Study Groups:
This trial has the following groups:- Group 1: Pulsed Lavage Washout
- Group 2: No Pulsed Lavage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.