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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Debridement Pad | Device | Study device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to immediately after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety by adverse events | Safety will be evaluated as incidence of device-related adverse events | From baseline to immediately after treatment |
| Time recorded for procedure | Time recorded for the debridement procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Castan, PhD | Hospital Carlos III | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Cres | Madrid | Spain |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D003668 | Pressure Ulcer |
| D000072836 | Surgical Wound |
| D002056 | Burns |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| From baseline to immediately after treatment |
| Removal of debris | Debris/necrosis/slough absorbed/ removed by the Debridement pad. | From baseline to immediately after treatment |
| Pain during procedure | Pain during the debridement procedure time frame assessed after procedure using the Visual Analogue scale. | 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. | 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. | 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. | From baseline to immediately after treatment |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |