Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial
| Registry | NCT05585710 |
|---|---|
| Status | Terminated - Changes in personnel |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 36 (Actual) |
| Sponsor | University of Alabama at Birmingham (Other) |
| Conditions | Breast Reconstruction |
| Interventions | Pulsed Lavage Washout, Implant-based breast reconstruction, Bilateral or unilateral mastectomy, Tissue expander, Acellular dermal matrix (Other, procedure, device) |
| Dates | start 2024-03-01, primary completion 2026-07-01, completion 2026-07-01, first posted 2022-10-19, last updated 2026-10-20 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Breast Reconstruction All trials of Pulsed Lavage Washout All trials of Implant-based breast reconstruction
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Pulsed Lavage Washout | Experimental | Other: Pulsed Lavage Washout; Procedure: Implant-based breast reconstruction; Procedure: Bilateral or unilateral mastectomy; Device: Tissue expander; Other: Acellular dermal matrix | 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. |
| No Pulsed Lavage | Active comparator | Procedure: Implant-based breast reconstruction; Procedure: Bilateral or unilateral mastectomy; Device: Tissue expander; Other: Acellular dermal matrix | 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. |
Sex: Female, ages: 18 Years to 75 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham, Alabama | United States |