Wound
Conditions
Keywords
Debridement
Brief summary
Documentation of the performance and safety of the debridement pad Cutimed DebriClean in daily clinical practice
Detailed 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.
Interventions
DEVICEmechanical debridement
The mechanical debridement is performed using the debridement pad Cutimed DebriClean. After the pad is moistened with wound-cleansing solution, the wound is cleaned using circular movements while applying gentle pressure.
Sponsors
BSN Medical GmbH
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of wound bed condition from baseline to assessment immediately after the mechanical debridement (within one study visit) | assessed immediately before and immediately after the mechanical debridement (within one study visit) | Percentage of wound coverage with debris/necrosis/slough Wound edge cleaned smooth Surrounding skin cleaned e.g. from skin flakes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound size after and before wound debridement | assessed immediately before and immediately after the mechanical debridement (within one study visit) | Wound length and wound width are measured using a wound ruler. Wound size is calculated using the formula A = length x width x π/4. |
| Debris/necrosis/slough absorbed by test product | assessed immediately after the mechanical debridement | assessed by the investigator (five categories) |
| Time needed for the debridement procedure | Time is measured during the debridement procedure | Time from start to completion of the debridement procedure in minutes |
| Pain during the debridement procedure | assessed immediately after the debridement procedure | Patient reported pain assessed using a visual analogue scale. If applicable, duration of pain is documented. |
| Adverse device effects | assessed immediately after the debridement procedure | Discomfort, pressure, burning sensation, bleeding, and irritation of the periwound skin during or after the mechanical debridement, other adverse device effects swelling; redness |
| Structural integrity of the test product | assessed immediately after the mechanical debridement | assessed by the investigator (e.g. change in shape, loosening of fibers, …) |
Countries
Germany, United Kingdom
Outcome results
None listed