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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT04884568
Eligibility Criteria:
Inclusion Criteria:
1. Female or male ≥18 years old.
2. Scheduled for a split skin graft transplantation of a partial thickness graft at a healthy and intact location at the thigh.
3. Planned hospitalization for at least 3 days post-transplantation.
4. Size of donor site treatable with an 15cm x 15cm Exufiber, with 2-3 cm additional overlap to dry surrounding skin.
5. Provision of written informed consent
Exclusion Criteria:
1. Burn injury of ≥20% of total body surface area.
2. Diagnosed with paraplegia.
3. Harvested graft from the same donor site location before.
4. Donor sites not to be harvested with dermatome
5. Pregnancy or lactation at the time of screening.
6. Known allergy/hypersensitivity to Exufiber, Mepilex or other components/products used in this investigation.
7. Participating in other ongoing clinical investigation that may impact the outcome of this investigation based on the judgement of the investigator.
8. Not able to read or understand Swedish.
9. Any other conditions that according to the investigator may make follow-up or investigation inappropriate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04884568
Study Brief:
Protocol Section:
NCT04884568