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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07316556
Eligibility Criteria:
Inclusion Criteria:
Wound according to indication mentioned in the instructions for use:
1. Superficial acute and chronic wounds with moderate to very high amounts of exudate and that are superficial, in:
* arterial and venous ulcers
* diabetic ulcers
* pressure ulcers
* post-traumatic wounds
* post-operative wounds healing by secondary intention
* skin graft donor sites
* oncological wounds
* ulcerating tumors
* wounds at risk of infection
* superficial 2nd degree burns
* lymphatic wounds
2. As secondary dressing on laparotomy wounds and fistulas or for deep wounds when used with appropriate wound filler
3. Patient has full legal capacity
4. Patient is able to understand and provide information
5. Patient has signed the written Informed Consent Form
Exclusion Criteria:
1. Age \< 18 years
2. Patient with contraindication:
* Known allergy and/or hypersensitivity to any of the product components.
* Not for use in tunnel-forming wound pockets, as the product may expand considerably with the absorption of wound exudate.
* Not for use on dry wounds.
3. Pregnant or lactating women
4. Patients participating in another clinical trial at the time of inclusion
5. Patient not covered by health insurance/social security
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07316556
Study Brief:
Protocol Section:
NCT07316556