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 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT06439459
Eligibility Criteria:
Inclusion Criteria:
* had undergone tissue expansion treatment;
* show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis (\<2mm) with no improvement after suspending expansion for 2 weeks;
* require further expansion to achieve the size for defect reconstruction.
Exclusion Criteria:
* Patients with serious underlying diseases such as cardiovascular or cerebrovascular disease, peripheral vascular disease, or impaired liver or kidney function;
* Patients with a long history of smoking and alcohol use who have not quit smoking or drinking;
* Patients allergic to iodine or iodine-containing preparations;
* Patients with psychiatric disorders, lack of insight, or those who cannot accurately express themselves or cooperate;
* Patients with contraindications for SVF transplantation, such as ulceration or infection of the expanded skin;
* Patients with severely loose skin or insufficient subcutaneous fat tissue;
* Patients who request to withdraw informed consent and exit the clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06439459
Study Brief:
Protocol Section:
NCT06439459