Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT04845256
Eligibility Criteria:
Inclusion Criteria:
* Aged 21 years or older; undergoing immediate pre-pectoral breast reconstruction after mastectomy (bilateral) with tissue expanders or implant
* Capable of providing informed consent
* Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.
Exclusion Criteria:
* Reconstruction is not post-mastectomy
* Pregnant or lactating females
* Patients needing more than 2 drains per breast
* Patients on steroids or other immune modulators known to impact healing
* Patients who are likely to not complete the study
* Patient who, in the opinion of the investigator, are unlikely to comply with the protocol
* Patients who have participated in this trial previously and who were withdrawn
* Patients with known allergies to contacting materials (i.e. latex, metal, etc.)
* Patients who received neoadjuvant chemotherapy or radiotherapy within the last 6 months
* Has any medical condition such as obesity (BMI\>40), uncontrolled diabetes (HbA1c\>7%) and/or immunosuppression.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT04845256
Study Brief:
Protocol Section:
NCT04845256