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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT02461433
Eligibility Criteria:
Inclusion Criteria:
* Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) / Medical Ethics Committee (MEC) of the respective clinical site.
* Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical Institutes.
* Patient with BMI≥ 30 at the time of surgery
* Patient agrees to return for all required clinical follow up for the study.
Exclusion Criteria:
* Known allergic reaction to acrylic adhesives or silver.
* Known history of intolerance to any component of Prevena Incision Management System TM.
* Very fragile skin around incision site.
* Bleeding disorder or refuses blood transfusion.
* Malignancy or other condition limiting life expectancy to \<5 years.
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02461433
Study Brief:
Protocol Section:
NCT02461433