Arterial Leg Ulcer, Burns and Scalds, Diabetic Ulcers, Postoperative Wound Healing, Pressure Ulcer, Surgical Wounds, Traumatic Wounds, Venous Leg Ulcer
Conditions
Brief summary
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.
Interventions
DEVICEDebridement Pad
Study device
Sponsors
Advanced Medical Solutions Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Wounds with both serous crusts and healthy tissue. * Minimum of 30% of the wound covered by debris, necrosis or slough. * Wound Size \> 4cm2
Exclusion criteria
* 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. * Symptoms \& signs of systemic and / or spreading wound infection (including erythema and fever). * Severe pain (level 7 or higher on a 0-10 VAS or hyperaesthesia in the wound area). * Subjects who in the view of the investigator might not be suitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the Debridement Pad | 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: 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety by adverse events | From baseline to immediately after treatment | Safety will be evaluated as incidence of device-related adverse events |
| Time recorded for procedure | From baseline to immediately after treatment | Time recorded for the debridement procedure |
| Removal of debris | From baseline to immediately after treatment | Debris/necrosis/slough absorbed/ removed by the Debridement pad. |
| Pain during procedure | From baseline to immediately after treatment | Pain during the debridement procedure time frame assessed after procedure using the Visual Analogue scale. |
| Overall clinician satisfaction | 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. |
| Patient tolerability | 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. |
| Device use wet or dry | From baseline to immediately after treatment | Use of the device when wet or dry (Specified, assessed using a Likert-type scale. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORPablo Castan, PhD
Hospital Carlos III
Outcome results
None listed