Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®)

Study Overview
=================
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.

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

Conditions
-----------------
Skin Transplantation

Intervention / Treatment
-----------------
* Device: FibDex®
* Device: Suprathel
* Device: Aquacel Foam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged at least 18 years when signing the informed consent Subjects with wounds that need split thickness skin grafting (STSG) 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: 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) Pregnant or breast-feeding women Subjects with solid organ transplantation Any other medical condition, compliance, or medication according to Investigator ́s evaluation considered as justified reason for exclusion Vulnerable subject (such as retarded person, person in nursing home, prisoner, patient in emergency) STSG donor site wound(s) on sensitive skin areas, such as the facial area, the genital area or mucous membranes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FibDex<br>IMD | Device: FibDex®<br>* To monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds.<br>|
| Active Comparator: Suprathel<br>Primary Comparator. | Device: Suprathel<br>* To monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds.<br>|
| Active Comparator: Aquacel Foam<br>Secondary Comparator. | Device: Aquacel Foam<br>* To monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Wound healing percentage (%) is evaluated by the investigator on POD 21 by removing the dressing and assessing the epithelization. | Post operative day 21 | 
| Wound healing | Wound healing percentage (%) is evaluated by the investigator | between post operative day 28-42, if not healed in 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject pain | Using a patient diary and NRS scale 0-10 (0= no pain,10= worst pain ever) | Diary for post operative days 0 to 21, NRS-scale 1 year. | 
| Epithelialization percentage | healing process evaluated by the investigator | post operative day 21 | 
| Scar quality | quality of the scar evaluated by patient | day 365 | 
| Scar quality | quality of the scar evaluated by observer (investigator) | 1 year | 
| Adverse events | Total number of adverse events and device defects | 1 year | 
| Workload during the study visits | To monitor the workload needed e.g. number of extra dressings before post operative day 21 evaluation by using case report forms | Post operative day 21 | 
| Safety of Investigational material | Number of IMD or comparator related adverse events | post operative day 21 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin Transplantation, Donor site, STSG, FibDex