PMCF Study to Examine the Debridement Pad Cutimed DebriClean

BSN Medical

Status: Completed

Conditions: Wound

Treatments: Device: mechanical debridement

Study type: Observational

Funder types: Industry

Identifiers

NCT04731753

BSN-C2533

Details and patient eligibility

About

Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice

Full description

60 subjects with superficial wounds in need of debridement will undergo mechanical debridement with the study product.

Per subject, one application of the study product will be documented including photo documentation of the wound and evaluation of the wound bed condition and wound size before and after the debridement.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects aged 18 years or older with full legal competence
• Signed informed consent
• Subjects with wounds in need of debridement, especially diabetic ulcers, venous and arterial ulcers, pressure sores, postoperative wounds and wounds healing by secondary intention, superficial burns
• Superficial wound
• Minimum 30 % of the wound is covered by debris, necrosis or slough
• Wound size > 4 cm²

Exclusion criteria

• Subjects not willing to participate or to attend the scheduled study visit
• Known sensitivity or allergy to the product components
• Severe pain or hyperaesthesia in the wound area
• Patients who are pregnant or lactating
• Drug abuse or alcohol abuse
• Patients who participate in any other clinical study investigating drugs or medical devices

Trial design

62 participants in 1 patient group

Group treated with study product

Description:

Subjects will undergo one mechanical debridement procedure with Cutimed DebriClean

Treatment:

Device: mechanical debridement