Wounds and Injuries

All Conditions

Skin and Connective Tissue Diseases

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Heart and Blood Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

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Ulcer

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Foot Ulcer

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Skin Diseases

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Cutimed® Gelling Fiber

Arne Böhling, Dr.

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.

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.

Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

Prospective Observational Explorative Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

Percentage of subjects with exudate absorbed by the IMD per visit

Percentage of subjects with remaining exudate in wound per amount and visit

Percentage of subjects with need for debridement per visit

Percentage of subjects per debridement ease ('easy', 'moderate', 'heavy', 'not applicable') per visit

Percentage of subjects per wound margin condition('intact', 'macerated', 'redness', 'ragged') per visit

Percentage of subjects per peri-wound skin condition ('intact', 'macerated', 'redness', 'dry/flaky', 'edematous' ,'weeping') per visit

Percentage of subjects per wound tissue type ('epithelialization tissue', 'granulation tissue', 'slough', 'eschar/necrotic tissue', 'other') per visit

Percentage of subjects per ease of application ('very easy', 'easy', 'difficult', 'very difficult') per visit

Percentage of subjects per conformability ('very good', 'good', 'poor', 'very poor') per visit

Percentage of subjects per ease of removal ('very easy', 'easy', 'difficult', 'very difficult') per visit

Percentage of subjects per adherence ('none', 'minor', 'moderate', 'marked') per visit

Mean pain perceived by subject using a pain ruler (scale 0-10) per visit

percentage change in Wound-QoL total scores and subscale scores ('body', 'psyche', 'everyday life' and standalone item) between both visits

Percentage per HCP overall satisfaction category ('Very good', 'Good', 'Satisfactory', 'Sufficient', 'Insufficient') for final visit

Percent of patient overall satisfaction category ('Very good', 'Good', 'Satisfactory', 'Sufficient', 'Insufficient') for all patients at visit 5

Total occurence of IMD related adverse events

Total occurence of IMD disintegration during removal

Spots Global Cancer Trial Database for pressure ulcer