Using pulsed lavage during breast reconstruction
Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial
This study is testing if using a special washing technique during breast reconstruction helps reduce complications like infections and fluid buildup after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05585710 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of pulsed lavage in washing out the mastectomy pocket during implant-based breast reconstruction. Participants will be randomly assigned to either receive the pulsed lavage treatment or not, with the primary focus on assessing post-operative complications such as surgical site infections, hematomas, seromas, and implant failures. Patients will be monitored for up to three months following the procedure to compare outcomes between the two groups.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 75 who are undergoing immediate implant-based breast reconstruction following mastectomy.
Not a fit: Patients who are male, under 18, over 75, or undergoing delayed expander breast reconstruction will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce post-operative complications and improve recovery outcomes for patients undergoing breast reconstruction.
How similar studies have performed: While the use of pulsed lavage in surgical procedures has been explored, this specific application in breast reconstruction is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Between 18 and 75 years of age, inclusive * Undergoing implant-based breast reconstruction (unilateral or bilateral) with immediate expander at mastectomy * Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document Exclusion Criteria: * Male * \< 18 years of age or \> 75 years of age * Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Richard J Fix, MD — University of Alabama at Birmingham
- Study coordinator: Ann C Braswell, BS
- Email: acb98@uab.edu
- Phone: 256-595-3846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.