PMCF Study of Debridement Pad

Advanced Medical Solutions Ltd.184 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

184

Conditions

Diabetic Ulcers Venous Leg Ulcer Arterial Leg Ulcer Pressure Ulcer Postoperative Wound Healing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.