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

NCT05148390 | Completed

• 1 other identifier: C2820
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Leg Ulcer; Diabetic Foot Ulcer; Pressure Ulcer; Surgical Wound; Abrasion; Laceration; Burn, Partial Thickness; Oncology Wound

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (16)

• Changes in need for debridement

  Throughout days 0, 7, 14, 21 and 28

• Changes in debridement ease

  Throughout days 0, 7, 14, 21 and 28

• Changes in wound margin condition

  Throughout days 0, 7, 14, 21 and 28

• Changes in peri-wound skin condition

  Throughout days 0, 7, 14, 21 and 28

• Changes in wound tissue type

  Throughout days 0, 7, 14, 21 and 28

Interventions

Cutimed® Gelling Fiber DEVICE

application of dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BSN Medical GmbH: lead

Study Sites (1)

Christliches Klinikum Melle GmbH, Unfallchirurgie

Melle, 49324, Germany

Location

MeSH Terms

Conditions

Leg Ulcer; Diabetic Foot; Pressure Ulcer; Surgical Wound; Lacerations; Burns

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Wounds and Injuries

Study Officials

• Arne Böhling, Dr.

  BSN Medical GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 8, 2021
• Study Start: April 24, 2022
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: February 21, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)