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.
Males or females aged 18 years or above.
Patients who can understand and give informed consent to take part in the study.
Have one or more of the following wounds: Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic and surgical wounds, and burns and scalds
Wounds that require debridement due to the presence of slough debris/fibrous tissue ,hyperkeratotic debris and dried exudate on the peri wound skin.
Patients who are known to be non-compliant with medical treatment
Patients who are known to be sensitive to any of the device components such as polyester.
Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study.
Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.
Single group
Debridement Pad
DeviceStudy device
Performance 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.
Safety by adverse events
Safety will be evaluated as incidence of device-related adverse events
Time recorded for procedure
Time recorded for the debridement procedure
Removal of debris
Debris/necrosis/slough absorbed/ removed by the Debridement pad.
Pain during procedure
Pain during the debridement procedure time frame assessed after procedure using the Visual Analogue scale.
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