Clinical trial NCT04884568: Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites
Official title: An Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm Performance and Safety of Exufiber When Used as Intended on Donor Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Wound
Donor Site
Split Skin Graft
Keywords: Post Market Clinical Follow-up
Exufiber
Gelling fibre dressing
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2021-05-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group of patients
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Change in wound progress
timeFrame: Day 14(-1 day), Day 21(+-1 day)
Secondary outcomes:
measure: Change in wound progress
timeFrame: Day 14(-1 day)
measure: Wound healing progress
timeFrame: Day 14(-1 day), Day 21(+-1 day)
measure: Follow-up assessment of wound healing when treated according to clinical praxis
timeFrame: Day 21(+-1 day)
measure: Wound size
timeFrame: Day 14(-1 day)
measure: Change in exudate amount and type
timeFrame: Day 14(-1 day), Day 21(+- 1 day)
measure: Local infection
timeFrame: Day 14(-1 day), Day 21(+- 1 day)
measure: Subject's pain
timeFrame: Day 14(-1 day), Day 21(+- 1 day)
measure: Subject's itching
timeFrame: Day 14(-1 day), Day 21(+- 1 day)
measure: Ability of dressing to absorb blood
timeFrame: Day 21(+-1 day)
measure: Ability of dressing to absorb exudate
timeFrame: Day 21(+-1 day)
measure: Ability of dressing to retain exudate
timeFrame: Day 21(+- 1 day)
measure: Ability of the dressing to retain blood
timeFrame: Day 21(+- 1 day)
measure: Exudate leakage
timeFrame: Day 21(+- 1 day)
measure: Blood leakage
timeFrame: Day 21(+- 1 day)
measure: Ability of dressing to stay in place
timeFrame: Day 21(+- 1 day)
measure: Ease of handling
timeFrame: Day 21(+-1 day)
measure: Ease of dressing removal
timeFrame: Day 21(+- 1 day)
measure: Dressing conformability
timeFrame: Day 21(+- 1 day)
measure: Dressing integrity
timeFrame: Day 21(+- 1 day)
measure: Comfort and experience
timeFrame: Day 21(+-1 day)
measure: Subject's quality of life assessment
timeFrame: Day 21(+- 1 day)
measure: Dressing wear time
timeFrame: Day 3, Day 14(-1 day), Day 21(+- 1 day)
measure: pH level measurement
timeFrame: Day 3
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital /Department of Hand and Plastic Surgery & Burn Center
Study officials:
References: