PMCF Study of Debridement Pad

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-07-10

Brief Summary

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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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Detailed Description

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Conditions

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Venous Leg Ulcer Arterial Leg Ulcer Pressure Ulcer Postoperative Wound Healing Traumatic Wounds Surgical Wounds Burns and Scalds Diabetic Ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Debridement Pad

Intervention Type DEVICE

Study device

Interventions

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Debridement Pad

Study device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No