Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites (ExuDS01)

Molnlycke Health Care

Status: Completed

Conditions: Acute Wound; Donor Site; Split Skin Graft

Treatments: Device: Exufiber

Study type: Interventional

Funder types: Industry

Identifiers

NCT04884568

ExuDS01

Details and patient eligibility

About

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.

Full 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

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Exufiber

Experimental group

Description:

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

Treatment:

Device: Exufiber