NCT04884568

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

An Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 will include eligible subjects undergoing split skin graft transplantation for harvesting of a partial-thickness skin graft, i.e. excision of the epidermis and part of the dermis. After the study inclusion (baseline) the patient will go through the split skin graft transplantation following application of the Exufiber® dressing, Mepilex®(non-border) dressing, and any third dressing as required on the donor site. Each subject will thereafter be followed up on days 3, 14, and 21 prior completion in the study. A subject may complete the study prior to or on day 14 as well as in between day 14 and day 21 if the donor site is healed. Wound healing progression will be determined by the investigator/designee and assessed as: * 100% re-epithelialisation including small residual scabs/blisters and open areas less than 1 cm within an otherwise fully re-epithelialised area, and/or * less than 100% re-epithelialization but to the extent that the Exufiber dressing is not required anymore If the donor site is not healed and the donor site is dry and therefor not treatable with Exufiber the patient will be treated according to clinical praxis and followed for outcomes on the following visits. Approximately 34 eligible subjects will be included in one centre in Sweden. The primary performance endpoint will be progression of donor site wound from baseline to last visit when Exufiber is used, up to 21 days. Wound progression will be determined by the investigator/designee and will be assessed as one of the following three outcomes: * Deteriorated * No change * Improved

Conditions

• Acute Wound
• Donor Site
• Split Skin Graft

Interventions

Type	Name	Description
DEVICE	Exufiber	Wound dressed with Exufiber for up to 21 days.

Timeline

• Start date: 2021-11-16
• Primary completion: 2023-05-09
• Completion: 2023-05-09
• First posted: 2021-05-13
• Last updated: 2023-09-08

Locations

1 site across 1 country: Sweden