Clinical trial NCT05148390: Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
Official title: Prospective Observational Explorative Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leg Ulcer
Diabetic Foot Ulcer
Pressure Ulcer
Surgical Wound
Abrasion
Laceration
Burn, Partial Thickness
Oncology Wound
Lead sponsor: BSN Medical GmbH
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Representativeness of the investigation population is assumed to be high in relation to the target population since this is a PMCF study, where the IMD will be used within the intended purpose including the intended patient population. Therefore, the IMD will be tested by the population for whom it is in fact intended for once placed on the market among other intended users. Inclusion and exclusion criteria are aligned with the product´s intended purpose.

No vulnerable subjects such as children, pregnant women, or sponsors or manufacturers staff will participate in this study guaranteed by specific inclusion and exclusion criteria.

Brief summary: This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients.

Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites.

During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.

Detailed description: This Post Market Clinical Follow up (PMCF) study will examine product features of the CE-marked wound dressing after having received market authorization regarding the fulfilment of predefined requirements for the successful management of skin integrity during wound care. The primary purpose of this study is to evaluate clinical safety and performance of the product when used on several wounds in routine wound care without any additional invasive or burdensome methods and within the intended use.

As primary objective the dressing´s absorption performance and its ability to prevent exudate accumulation in the wound will be investigated. Further, device disintegration, need of debridement, wound and skin conditions, treatment related pain, general wound pain, dressing adhesion and quality of life as well as Helath Care professional's (HCP´s) and patient´s satisfaction are considered as secondary outcomes.

In total, 36 eligible subjects will be enrolled at 2 German sites, including 15 % dropouts.

5 on-site visits are to be performed by the subjects in the scope of routine weekly wound care/dressing change visits during 28 days (Day 0, Day7, Day 14, Day21, Day28). The IMD will be applied during each on-site visit including wound care, wound examination/documentation and dressing change according to HCP's judgment and individual circumstances of the wound. Photographic documentation of the wound and the wound with applied dressings will be performed and used for further automatic wound/tissue analyis. General wound pain as well as pain perceived during dressing change will be documented, as well as Wound-related Quality of life as well as Patient's/HCP's satisfaction with the product.

Eligibility criteria: Inclusion Criteria:

* mentally and physically able to participate in study
* written informed consent to participate in the study
* Diagnosed wound indicated for treatment with Cutimed® Gelling Fiber for 4 weeks (except for internal body cavities and closed wounds)
* Subjects with more than one ulcer are eligible for inclusion, however only one ulcer per subject will be included in the study.

Exclusion Criteria:

* Sensitivity to or allergic reaction to the dressing or its components
* Participation in any other clinical study investigating drugs or medical devices
* Subjects presenting with wounds including internal body cavities or closed wounds
* Alcohol and drug addiction
* Pregnant or breast-feeding subjects
* Underlying diseases are not treated according to respective country-specific guidelines

Primary outcomes:
measure: Exudate absorption by IMD ('yes', 'no')
timeFrame: day 7
measure: Exudate absorption by IMD ('yes', 'no')
timeFrame: day 14
measure: Exudate absorption by IMD ('yes', 'no')
timeFrame: day 21
measure: Exudate absorption by IMD ('yes', 'no')
timeFrame: day 28
measure: Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
timeFrame: day 7
measure: Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
timeFrame: day 14
measure: Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
timeFrame: day 21
measure: Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
timeFrame: day 28
Secondary outcomes:
measure: Changes in need for debridement
timeFrame: Throughout days 0, 7, 14, 21 and 28
measure: Changes in debridement ease
timeFrame: Throughout days 0, 7, 14, 21 and 28
measure: Changes in wound margin condition
timeFrame: Throughout days 0, 7, 14, 21 and 28
measure: Changes in peri-wound skin condition
timeFrame: Throughout days 0, 7, 14, 21 and 28
measure: Changes in wound tissue type
timeFrame: Throughout days 0, 7, 14, 21 and 28
measure: Ease of application
timeFrame: Throughout days 0, 7, 14, 21 and 28
measure: Conformability during application
timeFrame: Throughout days 0, 7, 14, 21 and 28
measure: Ease of removal
timeFrame: Throughout days 7, 14, 21 and 28
measure: Dressing adherence on removal
timeFrame: Throughout days 7, 14, 21 and 28
measure: Pain on removal
timeFrame: Throughout days 7, 14, 21 and 28
measure: Changes in wound-pain
timeFrame: Throughout days 7, 14, 21 and 28
measure: Changes in Wound-quality of life Wound-QoL
timeFrame: Day 0 and Day 28
measure: HCP Overall satisfaction
timeFrame: day 28
measure: Subject Overall satisfaction
timeFrame: day 28
measure: Incidence of adverse events related to IMD
timeFrame: Throughout days 0, 7, 14, 21 and 28
measure: Incidence of device disintegration (removability in one piece)
timeFrame: Throughout days 0, 7, 14, 21 and 28
Other outcomes:
Locations:
city: Melle
country: Germany
facility: Christliches Klinikum Melle GmbH, Unfallchirurgie
Study officials:
affiliation: BSN Medical GmbH
name: Arne Böhling, Dr.
role: STUDY_DIRECTOR
References: