Pre-pectoral Breast Reconstruction With or Without Mesh (NCT05888571) | Clinical Trial Compass
RecruitingNot Applicable
Pre-pectoral Breast Reconstruction With or Without Mesh
China164 participantsStarted 2023-07-01
Plain-language summary
To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.
Who can participate
Age range
18 Years – 65 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
. Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
. SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
. The blood perfusion of breast skin flap was well;
. Do not smoking in the last 4 weeks or more
. Patients with normal expectations and mental health for breast reconstruction;
. Signed consent to participate
Exclusion criteria
. Poor perfusion of breast mastectomy flap;
. II stage breast reconstruction patients;
. History of chest radiotherapy;
. BMI greater than 35;
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
1
Major Complication Rates
Timeframe: up to 12 months after surgery
2
Patient Breast-Q questionnaire
Timeframe: up to 12 months after surgery
Trial details
NCT IDNCT05888571
SponsorTianjin Medical University Cancer Institute and Hospital