Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites

NCT04884568 | Completed

• 1 other identifier: ExuDS01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 intended on donor sites through assessment of wound progression from baseline to the subject´s last visit.

Conditions

Acute Wound; Donor Site; Split Skin Graft

Keywords

Post Market Clinical Follow-up; Exufiber; Gelling fibre dressing

Outcome Measures

Primary Outcomes (1)

• Change in wound progress

  Wound progress compared between each visit up to final visit and assessed as: * Deteriorated * No change * Improved

  Day 14(-1 day), Day 21(+-1 day)

Secondary Outcomes (23)

• Change in wound progress

  Day 14(-1 day)

• Wound healing progress

  Day 14(-1 day), Day 21(+-1 day)

• Follow-up assessment of wound healing when treated according to clinical praxis

  Day 21(+-1 day)

• Wound size

  Day 14(-1 day)

• Change in exudate amount and type

  Day 14(-1 day), Day 21(+- 1 day)

Study Arms (1)

Exufiber

EXPERIMENTAL

This is an open, non-randomised , single arm study

Device: Exufiber

Interventions

Exufiber DEVICE

Wound dressed with Exufiber for up to 21 days.

Exufiber

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (1)

Linköping University Hospital /Department of Hand and Plastic Surgery & Burn Center

Linköping, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group of patients

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: November 16, 2021
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)