Clínica Cres
Madrid, Spain
NCT Number: NCT07255937
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Madrid, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study device
Time frame: From baseline to immediately after treatment
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:
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 will be evaluated as incidence of device-related adverse events
Time frame: From baseline to immediately after treatment
Time recorded for the debridement procedure
Time frame: From baseline to immediately after treatment
Debris/necrosis/slough absorbed/ removed by the Debridement pad.
Time frame: From baseline to immediately after treatment
Pain during the debridement procedure time frame assessed after procedure using the Visual Analogue scale.
Time frame: From baseline to immediately after treatment
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
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
Use of the device when wet or dry (Specified, assessed using a Likert-type scale.
Advanced Medical Solutions Ltd.
Industry
Post Market Clinical Follow up Study to Confirm the Ongoing Safety and Performance of a Debridement Pad in Superficial, Chronic and Acute Wounds
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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