Clinical trial NCT05666999: Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®)
Official title: Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®) to Compare the Clinical Performance and Safety in it's Established Intended Use of Split Thickness Skin Graft Donor Site Wounds
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin Transplantation
Keywords: Skin Transplantation
Donor site
STSG
FibDex
Lead sponsor: UPM Biomedicals
Sponsor class: INDUSTRY
Collaborators: name: Helsinki University Central Hospital
First posted: 2022-12-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: FibDex® 2-2022 is a sponsored, post-marketing clinical follow-up (PMCF) study to monitor the clinical performance and safety of the CE marked product nanofibrillar cellulose (NFC) wound dressing, FibDex®, when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds and to compare clinical performance and safety of FibDex® to current clinical practice.

Detailed description: STSG is a reconstructive procedure that is most used for management of burn injuries. Skin harvesting creates a new partial thickness wound, a donor site that causes additional pain for the patient during the postoperative recovery. Therefore, and because wound healing complications, such as delayed healing and infections, are common donor sites, the donor sites are problematic to treat. A dressing that wound provide optimal healing, low costs, and minimal pain with few dressing changes would be a preferred choice for treatment of donor sites. NFC wound dress, like FibDex, are used for providing these kinds of benefits to patients and better healing result.

This is a sponsored prospective, randomized, controlled, non-blinded, non-inferiority study. Subjects will be treated with the IMD or the comparator and act as their own controls. Subjects will be followed up for up to POD 365. Purpose of this PMCF study for FibDex is to gather data for updating the clinical evaluation and assess if new data gained over time has a bearing on the risk-benefit assessment or if there are some needs to make changes to the product or the package. Clinical evaluation is ongoing and happens throughout the medical devices lifetime. Clinical safety need to be analyzed periodically according to MDR requirements. For class IIb products, like FibDex, it means clinical safety update every year. This study is part of that evaluation.

Aim is to get 48 randomized STSG wounds. Study methods during this study are using the IMD or the comparator after the surgery, subject diaries, pain questionnaires, scar quality assessments by investigator and study subjects and visual observation by the delegated site staff. Also, photos of the healing process will be collected.

Eligibility criteria: Inclusion Criteria:

1. Subjects aged at least 18 years when signing the informed consent
2. Subjects with wounds that need split thickness skin grafting (STSG)
3. Subjects that have at least one STSG donor site wound at least 5 x 5 cm and maximum 20 x 30 cm or two STSG donor site wounds of same size, at least 5 x 5 cm and maximum 20 x 30 cm, anatomically close to each other or on anatomically similar area in the opposite extremity or body area.

Exclusion Criteria:

1. Subjects allergic to, or have had an allergic reaction to IMDs components (wood cellulose and polypropylene) or the comparator's components (polylactic acid-based copolymer or natrium carboxymethylcellulose)
2. Pregnant or breast-feeding women
3. Subjects with solid organ transplantation
4. Any other medical condition, compliance, or medication according to Investigator ́s evaluation considered as justified reason for exclusion
5. Vulnerable subject (such as retarded person, person in nursing home, prisoner, patient in emergency)
6. STSG donor site wound(s) on sensitive skin areas, such as the facial area, the genital area or mucous membranes.

Primary outcomes:
measure: Wound healing
timeFrame: Post operative day 21
measure: Wound healing
timeFrame: between post operative day 28-42, if not healed in 3 weeks
Secondary outcomes:
measure: Subject pain
timeFrame: Diary for post operative days 0 to 21, NRS-scale 1 year.
measure: Epithelialization percentage
timeFrame: post operative day 21
measure: Scar quality
timeFrame: day 365
measure: Scar quality
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
measure: Workload during the study visits
timeFrame: Post operative day 21
measure: Safety of Investigational material
timeFrame: post operative day 21
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
affiliation: Director, Quality Assurance
name: Kari Luukko, Dr.Tech
role: STUDY_DIRECTOR
References: