Status:
COMPLETED
Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Acute Wound
Donor Site
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single-centre prospective, open, non-comparative, Post-Market Clinical Follow-up (PMCF) investigation to confirm performance and safety of Exufiber® (Gelling fibre dressing) when used as int...
Detailed Description
A single-centre prospective, open, non-comparative, PMCF investigation to confirm performance and safety of Exufiber® (gelling fibre dressing) when used as intended on donor sites. The investigation w...
Eligibility Criteria
Inclusion
- Female or male ≥18 years old.
- Scheduled for a split skin graft transplantation of a partial thickness graft at a healthy and intact location at the thigh.
- Planned hospitalization for at least 3 days post-transplantation.
- Size of donor site treatable with an 15cm x 15cm Exufiber, with 2-3 cm additional overlap to dry surrounding skin.
- Provision of written informed consent
Exclusion
- Burn injury of ≥20% of total body surface area.
- Diagnosed with paraplegia.
- Harvested graft from the same donor site location before.
- Donor sites not to be harvested with dermatome
- Pregnancy or lactation at the time of screening.
- Known allergy/hypersensitivity to Exufiber, Mepilex or other components/products used in this investigation.
- Participating in other ongoing clinical investigation that may impact the outcome of this investigation based on the judgement of the investigator.
- Not able to read or understand Swedish.
- Any other conditions that according to the investigator may make follow-up or investigation inappropriate.
Key Trial Info
Start Date :
November 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04884568
Start Date
November 16 2021
End Date
May 9 2023
Last Update
September 8 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Linköping University Hospital /Department of Hand and Plastic Surgery & Burn Center
Linköping, Sweden