RECRUITING

Pulsed Lavage in Implant-Based Breast Reconstruction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-01
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05585710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Between 18 and 75 years of age, inclusive
  3. * Undergoing implant-based breast reconstruction (unilateral or bilateral) with immediate expander at mastectomy
  4. * Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document
  1. * Male
  2. * \< 18 years of age or \> 75 years of age
  3. * Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy

Contacts and Locations

Study Contact

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

Principal Investigator

Richard J Fix, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Richard J Fix, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • breast reconstruction
  • implant-based breast reconstruction
  • pulsed lavage

Additional Relevant MeSH Terms

  • Breast Reconstruction