PMCF Study of Debridement Pad

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdvanced Medical Solutions Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Debridement Pad

Treatment groups

184 Participants
are divided into 1 treatment group