The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic or surgical wounds and burns and scalds. The performance data from this study will support clinically meaningful rates of successful improvement in wound bed condition immediately after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Study device
Clínica Cres
Madrid, Spain
RECRUITINGPerformance of the Debridement Pad
Performance of the Debridement Pad on Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic and surgical wounds, and burns and scalds. Success will be determined by the following: 1\. Change of wound bed condition from baseline (pre debridement) to assessment immediately after the use of the debridement pad as defined as a. Percentage reduction of wound coverage of visible debris/necrosis/slough from the wound bed at baseline assessment and after procedure.
Time frame: From baseline to immediately after treatment
Safety by adverse events
Safety will be evaluated as incidence of device-related adverse events
Time frame: From baseline to immediately after treatment
Time recorded for procedure
Time recorded for the debridement procedure
Time frame: From baseline to immediately after treatment
Removal of debris
Debris/necrosis/slough absorbed/ removed by the Debridement pad.
Time frame: From baseline to immediately after treatment
Pain during procedure
Pain during the debridement procedure time frame assessed after procedure using the Visual Analogue scale.
Time frame: From baseline to immediately after treatment
Overall clinician satisfaction
Clinician satisfaction with the device (conformability, ease of use, use of both sides, softness, integrity) will be assessed using a Likert-type scale.
Time frame: From baseline to immediately after treatment
Patient tolerability
Tolerability of the patient assessed by the clinician (assessing discomfort, pressure, burning sensation, Pain, irritation of peri wound skin, swelling and redness), assessed using a Likert-type scale.
Time frame: From baseline to immediately after treatment
Device use wet or dry
Use of the device when wet or dry (Specified, assessed using a Likert-type scale.
Time frame: From baseline to immediately after treatment
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