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

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 causesadditional pain for the patient during the postoperative recovery. Therefore, and becausewound healing complications, such as delayed healing and infections, are common donorsites, the donor sites are problematic to treat. A dressing that wound provide optimalhealing, low costs, and minimal pain with few dressing changes would be a preferredchoice for treatment of donor sites. NFC wound dress, like FibDex, are used for providingthese kinds of benefits to patients and better healing result.This is a sponsored prospective, randomized, controlled, non‐blinded, non‐inferioritystudy. Subjects will be treated with the IMD or the comparator and act as their owncontrols. Subjects will be followed up for up to POD 365. Purpose of this PMCF study forFibDex is to gather data for updating the clinical evaluation and assess if new datagained over time has a bearing on the risk‐benefit assessment or if there are some needsto make changes to the product or the package. Clinical evaluation is ongoing and happensthroughout the medical devices lifetime. Clinical safety need to be analyzed periodicallyaccording to MDR requirements. For class IIb products, like FibDex, it means clinicalsafety 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 theIMD or the comparator after the surgery, subject diaries, pain questionnaires, scarquality assessments by investigator and study subjects and visual observation by thedelegated site staff. Also, photos of the healing process will be collected.