UAB - Center for Clinical and Translational Science

Pulsed Lavage in Implant-Based Breast Reconstruction

Purpose

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.

Condition

Breast Reconstruction

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: Female
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two cohorts will be established. One cohort will include patients who undergo pulsed lavage to wash out the mastectomy pocket. The other cohort will include patients who do not receive pulsed lavage.
Primary Purpose: Prevention
Masking: None (Open Label)
Masking Description: Pulsed Lavage is a surgical technique that cannot be masked from the investigators performing the operation.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Pulsed Lavage Washout	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.	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 Procedure: Bilateral or unilateral mastectomy Standard of care Device: Tissue expander Standard of care Other: Acellular dermal matrix Standard of care
Active Comparator No Pulsed Lavage	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.	Procedure: Implant-based breast reconstruction Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket Procedure: Bilateral or unilateral mastectomy Standard of care Device: Tissue expander Standard of care Other: Acellular dermal matrix Standard of care

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

Contact:
Ann C Braswell, BS
256-595-3846
acb98@uab.edu

More Details

Status: Recruiting
Sponsor: University of Alabama at Birmingham

Study Contact

Ann C Braswell, BS
256-595-3846
acb98@uab.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.