PMCF Study of Debridement Pad

Advanced Medical Solutions

Status

Enrolling

Conditions

Burns and Scalds

Venous Leg Ulcer

Surgical Wounds

Diabetic Ulcers

Traumatic Wounds

Pressure Ulcer

Arterial Leg Ulcer

Postoperative Wound Healing

Treatments

Device: Debridement Pad

Study type

Interventional

Funder types

Industry

Identifiers

NCT07255937

Debridement Pad 001

Details and patient eligibility

About

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.

Enrollment

184 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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