WithdrawnNot Applicable

Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction

Stopped: Principal Investigator left institution

United States0Started 2023-10-01

Plain-language summary

The purpose of this study is to investigate the to analyze the patient satisfaction and complication rates under controlled conditions of the increasingly popular prepectoral technique for implant-based breast reconstruction.

Who can participate

Age range

19 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction Exclusion Criteria: * Active use of any tobacco products * Uncontrolled diabetes defined by HbA1c greater than 7.5% * Class II obesity or higher defined by a body mass index equal or greater than 35 kg/m2 * History of radiation to the affect breast or chest * Immunocompromised patients * Clinical evidence of significant mastectomy flap ischemia prior to the initiation of the reconstructive procedure

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient satisfaction as measured by BREAST-Q-scores

Timeframe: Preoperatively

Patient satisfaction as measured by BREAST-Q-scores

Timeframe: postoperative day 90 +/-30 days

Trial details

NCT IDNCT04874402

SponsorCase Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Breast Reconstruction Following Mastectomy trials