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NCT05585710 Clinical Trial

Pulsed Lavage in Implant-Based Breast Reconstruction

Breast Reconstruction Clinical Trial

Official title:
Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05585710
Other study ID # IRB-300009900
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date August 2025

Study information
Verified date March 2024
Source University of Alabama at Birmingham
Contact Ann C Braswell, BS
Phone 256-595-3846
Email acb98@uab.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.

Description:

After being informed of the study including potential risks and benefits, all patients giving consent who meet eligibility requirements will undergo randomization into either the pulsed lavage arm (receive mastectomy pocket wash out using pulsed lavage) or the no pulsed lavage arm (pulsed lavage will not be used). Randomization will occur using a random number generator with even numbers resulting in a pulsed lavage washout and odd numbers resulting in no pulsed lavage washout. The patients will be followed in clinic for a maximum of 3 months to evaluate the surgical site. The two cohorts will be compared at the end of the study to determine whether there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction.

Recruitment information / eligibility
Status Recruiting
Enrollment 62
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Pulsed Lavage Washout
Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket
Procedure:
• Implant-based breast reconstruction
Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
• Bilateral or unilateral mastectomy
Standard of care
Device:
• Tissue expander
Standard of care
Other:
• Acellular dermal matrix
Standard of care

Locations
Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-op Complications unintended complications that occur post-surgically up to 3 months
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