Pulsed Lavage in Implant-Based Breast Reconstruction

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05585710

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Reconstruction	Other: Pulsed Lavage Washout Procedure: Implant-based breast reconstruction Procedure: Bilateral or unilateral mastectomy Device: Tissue expander Other: Acellular dermal matrix	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

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.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.

Masking:

None (Open Label)

Masking Description:

Pulsed Lavage is a surgical technique that cannot be masked from the investigators performing the operation.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 normal saline to irrigate mastectomy pocket Procedure: Implant-based breast reconstruction Standard of care 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 Procedure: Bilateral or unilateral mastectomy Standard of care Device: Tissue expander Standard of care Other: Acellular dermal matrix Standard of care

Arm

Intervention/Treatment

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 normal saline to irrigate mastectomy pocket

Procedure: Implant-based breast reconstruction

Standard of care

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

Procedure: Implant-based breast reconstruction

Standard of care

Procedure: Bilateral or unilateral mastectomy

Standard of care

Device: Tissue expander

Standard of care

Other: Acellular dermal matrix

Standard of care

Outcome Measures

Primary Outcome Measures

Post-op Complications [up to 3 months]
unintended complications that occur post-surgically

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator: Prasanth Patcha, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prasanth Patcha, Assistant Professor in the Department of Plastic Surgery, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT05585710

Other Study ID Numbers:

IRB-300009900

First Posted:

Oct 19, 2022

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prasanth Patcha, Assistant Professor in the Department of Plastic Surgery, University of Alabama at Birmingham

breast reconstruction

implant-based breast reconstruction

pulsed lavage

Study Results

No Results Posted as of Jan 26, 2023