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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Reconstruction

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