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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT03089060
Eligibility Criteria:
Inclusion Criteria:
* full skin substances defects distal to the distal interphalangeal joint (DIP-joint) unsuitable for primary surgical closure without further substance loss
* no more than five fingers per patient may be injured
* circumference of the proximal phalanx in between 3.0 cm and 9.0 cm
* signed informed consent
Exclusion Criteria:
* known hypersensitivity against medical silicone or self-adhesive films
* bony injuries requiring a surgical intervention
* bite injuries
* chronic dermatologic disorders of the hand
* intake of medications affecting wound healing, for instance/such as systemic (non-inhalative) glucocorticoids, immunosuppressive or blood-thinning medications
* known wound healing disorders
* ongoing or recently finished chemotherapy
* primary/congenital immunodeficiency
* diabetes mellitus
* pregnant or breastfeeding patients/women, as well as any women, when a pregnancy at the beginning or during the course of the study cannot be excluded (i.e. post-menopausal, oophorectomy or hysterectomy, contraceptive method with pearl index less than 1 %, sexual abstinence or partner with vasectomy)
* addiction or other diseases, which do not allow to assess the entity, scope and possible consequences of this clinical trial
* not cooperative patients
* participation in a clinical trial within the last four weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT03089060
Study Brief:
Protocol Section:
NCT03089060