- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509037
Evaluation of Breast Reduction Techniques
December 6, 2024 updated by: Herman Houin, MD, Henry Ford Health System
Breast Reductions: Retrospective Evaluation of Suction Assisted Breast Reduction with Peri-Areolar Mastopexy Compared to Longer Incision Pedicle Breast Reduction Techniques
The purpose of this study is to retrospectively evaluate breast reduction techniques in terms of complications, functionality, patient satisfaction, and cosmetic outcomes.
Study Overview
Status
Recruiting
Conditions
Detailed Description
A breast reduction is a common operation with a fairly high complication rate as large incision techniques require undermined skin flaps to be closed under tension.
This study is evaluation the open incision breast reduction technique to a liposuction assisted breast reduction.
This study will evaluate these two breast reduction techniques in terms of complication rates, functionality, patient satisfaction, and cosmetic outcomes.
Participants will be asked to complete the BREAST-Q survey regarding their breast reduction postoperatively.
Study Type
Observational
Enrollment (Estimated)
490
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Health System
-
Contact:
- Herman Houin, MD
- Phone Number: 313-916-2378
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patients who underwent a breast reduction between 2013 and 2019.
Description
Inclusion Criteria:
- Patients who underwent a breast reduction between 2013 and 2019
- All patients who underwent a liposuction assisted or layered skin incision pedicled technique breast reduction.
Exclusion Criteria:
- Patients who underwent additional procedures simultaneously at the time of the breast reduction.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Liposuction Assisted Breast Reduction
|
|
Open Incision Breast Reduction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Complication Rate
Time Frame: Postoperative Period (Average of 1 year following surgery)
|
To determine if liposuction assisted breast reduction has a lower postoperative complication rate as opposed to open incision breast reduction
|
Postoperative Period (Average of 1 year following surgery)
|
|
Breast Reduction Success Rate
Time Frame: Postoperative Period (Average of 1 year following surgery)
|
To determine if liposuction assisted breast reduction has a higher success rate as opposed to open incision breast reduction based on postoperative outcomes.
|
Postoperative Period (Average of 1 year following surgery)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Actual)
August 8, 2012
Primary Completion (Estimated)
December 12, 2025
Study Completion (Estimated)
June 12, 2026
Study Registration Dates
First Submitted
June 12, 2020
First Submitted That Met QC Criteria
August 10, 2020
First Posted (Actual)
August 11, 2020
Study Record Updates
Last Update Posted (Estimated)
December 11, 2024
Last Update Submitted That Met QC Criteria
December 6, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7372
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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