Clinical Outcomes and Complications in Two-stage Breast Reconstruction Using Microtextured and Na… (NCT07442838) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Outcomes and Complications in Two-stage Breast Reconstruction Using Microtextured and Nanotextured Expanders
Slovakia88 participantsStarted 2025-06-24
Plain-language summary
This retrospective observational study evaluates clinical outcomes and complication rates in women who underwent two-staged implant-based breast reconstruction using tissue expanders and implants following mastectomy for breast cancer. The study focuses on comparing postoperative complications associated with nano- and microtextured tissue expanders and assessing the influence of prior radiotherapy on reconstructive outcomes.
The hypothesis of the study is that the surface characteristics of tissue expanders and a history of radiotherapy may influence the incidence and type of postoperative complications as well as overall reconstructive success.
Who can participate
Sex
ALL
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:
* History of mastectomy for breast cancer or prophylactic mastectomy
* Undergoing two-stage breast reconstruction
* Reconstruction performed using tissue expanders and implants
* Availability of complete medical documentation
* Regular follow-up visits
Exclusion Criteria:
* Reconstruction using autologous tissue
* Reconstruction using permanent expander
* Single-stage Reconstruction using implant
* Incomplete clinical documentation
* Missing follow-up data relevant to complication assessment
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
Association Between Expander Surface Type and Complications
Timeframe: Up to 12 months after reconstruction surgery