Actively Recruiting
Post Market Clinical Follow-up Study to Confirm Safety and Performance of a Debridement Pad in Superficial, Chronic, and Acute Wounds
Led by Advanced Medical Solutions Ltd. · Updated on 2025-12-01
184
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a Debridement Pad in people with various superficial, chronic, and acute wounds. These wounds include diabetic ulcers, arterial and venous leg ulcers, pressure ulcers, postoperative wounds healing by secondary intention, traumatic or surgical wounds, and burns or scalds. The study aims to collect performance data to show meaningful improvement in the condition of the wound bed immediately after treatment. Participants will receive treatment using the Debridement Pad device, which is designed to remove debris such as slough, fibrous tissue, hyperkeratotic debris, and dried exudate from wounds. The study focuses on wounds that have at least 30% coverage of debris, necrosis, or slough and are larger than 4 cm2. The treatment is applied once, and the immediate effects on the wound bed are assessed. During the study, researchers will evaluate the performance of the Debridement Pad from baseline to immediately after treatment. They will measure safety by monitoring adverse events, the time taken for the procedure, removal of debris, pain experienced during the procedure, clinician satisfaction, patient tolerability, and whether the device is used wet or dry. Participants will be followed only through the treatment and immediate post-treatment period. The total study participation duration is limited to this short timeframe.
CONDITIONS
Brief Title
PMCF Study of Debridement Pad
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, or 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 greater than 4 cm2
You will not qualify if you...
- 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 would interfere with their ability to participate
- Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment
- Symptoms and signs of systemic and/or spreading wound infection, including erythema and fever
- Severe pain (level 7 or higher on a 0-10 pain scale) or hyperaesthesia in the wound area
- Subjects who might not be suitable for inclusion in the study in the investigator's view
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment occurs during a single procedure lasting minutes to hours
Participants receive treatment with the Debridement Pad to remove debris and promote wound healing.
1 treatment visit (in-person)
Trial Site Locations
Total: 1 location
1
Clínica Cres
Madrid, Spain
Actively Recruiting
Research Team
C
Charlotte E Moss, PhD
R
Rebecca Forder, BA (Hons)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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