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

Skin Transplantation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666999
• Other study ID #: FibDex 2-2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: UPM Biomedicals
• Contact: Laura Punakallio
• Phone: +358(0)20415111
• Email: laura.punakallio[@]upm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Transplantation

Intervention

Device:
• FibDex®
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.
• Suprathel
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.
• Aquacel Foam
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
UPM Biomedicals	Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Wound healing	Wound healing percentage (%) is evaluated by the investigator	between post operative day 28-42, if not healed in 3 weeks
Secondary	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.
Secondary	Epithelialization percentage	healing process evaluated by the investigator	post operative day 21
Secondary	Scar quality	quality of the scar evaluated by patient	day 365
Secondary	Scar quality	quality of the scar evaluated by observer (investigator)	1 year
Secondary	Adverse events	Total number of adverse events and device defects	1 year
Secondary	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
Secondary	Safety of Investigational material	Number of IMD or comparator related adverse events	post operative day 21