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

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

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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcer; Surgical Wound; Diabetic Foot Ulcer; Pressure Ulcer; Laceration; Burn, Partial Thickness; Abrasion; Oncology Wound
• Intervention / Treatment: Device: Cutimed® Gelling Fiber

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Germany
  • Melle, Germany, 49324
    • Christliches Klinikum Melle GmbH, Unfallchirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exudate absorption by IMD ('yes', 'no')	Percentage of subjects with exudate absorbed by the IMD per visit	day 7
Exudate absorption by IMD ('yes', 'no')	Percentage of subjects with exudate absorbed by the IMD per visit	day 14
Exudate absorption by IMD ('yes', 'no')	Percentage of subjects with exudate absorbed by the IMD per visit	day 21
Exudate absorption by IMD ('yes', 'no')	Percentage of subjects with exudate absorbed by the IMD per visit	day 28
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')	Percentage of subjects with remaining exudate in wound per amount and visit	day 7
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')	Percentage of subjects with remaining exudate in wound per amount and visit	day 14
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')	Percentage of subjects with remaining exudate in wound per amount and visit	day 21
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')	Percentage of subjects with remaining exudate in wound per amount and visit	day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in need for debridement	Percentage of subjects with need for debridement per visit	Throughout days 0, 7, 14, 21 and 28
Changes in debridement ease	Percentage of subjects per debridement ease ('easy', 'moderate', 'heavy', 'not applicable') per visit	Throughout days 0, 7, 14, 21 and 28
Changes in wound margin condition	Percentage of subjects per wound margin condition('intact', 'macerated', 'redness', 'ragged') per visit	Throughout days 0, 7, 14, 21 and 28
Changes in peri-wound skin condition	Percentage of subjects per peri-wound skin condition ('intact', 'macerated', 'redness', 'dry/flaky', 'edematous' ,'weeping') per visit	Throughout days 0, 7, 14, 21 and 28
Changes in wound tissue type	Percentage of subjects per wound tissue type ('epithelialization tissue', 'granulation tissue', 'slough', 'eschar/necrotic tissue', 'other') per visit	Throughout days 0, 7, 14, 21 and 28
Ease of application	Percentage of subjects per ease of application ('very easy', 'easy', 'difficult', 'very difficult') per visit	Throughout days 0, 7, 14, 21 and 28
Conformability during application	Percentage of subjects per conformability ('very good', 'good', 'poor', 'very poor') per visit	Throughout days 0, 7, 14, 21 and 28
Ease of removal	Percentage of subjects per ease of removal ('very easy', 'easy', 'difficult', 'very difficult') per visit	Throughout days 7, 14, 21 and 28
Dressing adherence on removal	Percentage of subjects per adherence ('none', 'minor', 'moderate', 'marked') per visit	Throughout days 7, 14, 21 and 28
Pain on removal	Mean pain perceived by subject using a pain ruler (scale 0-10) per visit	Throughout days 7, 14, 21 and 28
Changes in wound-pain	Mean pain perceived by subject using a pain ruler (scale 0-10) per visit	Throughout days 7, 14, 21 and 28
Changes in Wound-quality of life Wound-QoL	percentage change in Wound-QoL total scores and subscale scores ('body', 'psyche', 'everyday life' and standalone item) between both visits	Day 0 and Day 28
HCP Overall satisfaction	Percentage per HCP overall satisfaction category ('Very good', 'Good', 'Satisfactory', 'Sufficient', 'Insufficient') for final visit	day 28
Subject Overall satisfaction	Percent of patient overall satisfaction category ('Very good', 'Good', 'Satisfactory', 'Sufficient', 'Insufficient') for all patients at visit 5	day 28
Incidence of adverse events related to IMD	Total occurence of IMD related adverse events	Throughout days 0, 7, 14, 21 and 28
Incidence of device disintegration (removability in one piece)	Total occurence of IMD disintegration during removal	Throughout days 0, 7, 14, 21 and 28

Collaborators and Investigators

• Sponsor: BSN Medical GmbH
• Investigators: Study Director: Arne Böhling, Dr., BSN Medical GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2022
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries; Surgical Wound; Leg Ulcer; Pressure Ulcer; Lacerations
• Other Study ID Numbers: C2820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No