Debridement pad to clean and improve chronic and acute wounds

Post Market Clinical Follow up Study to Confirm the Ongoing Safety and Performance of a Debridement Pad in Superficial, Chronic and Acute Wounds

This trial will test a debridement pad to clean and improve wound beds in adults with diabetic, venous or arterial leg ulcers, pressure ulcers, postoperative wounds, traumatic/surgical wounds, or burns that need debridement.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Advanced Medical Solutions Ltd. (industry)
• Locations: 1 site (Madrid)
• Trial ID: NCT07255937 on ClinicalTrials.gov

What this trial studies

This interventional post‑market study applies a debridement pad to adults with superficial chronic or acute wounds that require removal of slough, fibrin, crusts, or dried exudate. Eligible wounds must be larger than 4 cm² and have at least 30% of the area covered by debris, necrosis, or slough. Investigators will apply the pad and record immediate changes in wound bed condition to generate performance data. The results will be used to support clinically meaningful rates of successful improvement immediately after treatment.

Who should consider this trial

Good fit: Adults (≥18 years) with diabetic, arterial or venous leg ulcers, pressure ulcers, postoperative wounds healing by secondary intention, traumatic or surgical wounds, or burns that require debridement and have at least 30% of the wound covered by debris and a wound size >4 cm² are ideal candidates.

Not a fit: Patients who are known to be sensitive to device components (e.g., polyester), are non‑compliant with medical treatment, or have significant unstable medical or psychiatric conditions that would interfere with participation are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the pad could more quickly and effectively clear slough and debris, improving the wound bed and potentially facilitating faster healing with less manual debridement.

How similar studies have performed: Other mechanical and soft debridement devices and pads have demonstrated effectiveness at removing slough and improving wound bed condition in prior clinical reports, so this approach is an extension of established methods.

Eligibility criteria

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

Where this trial is running

Madrid

• Clínica Cres — Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Pablo Castan, PhD — Hospital Carlos III
• Study coordinator: Charlotte E Moss, PhD

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