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New Wound-Cleaning pad could speed healing

NCT ID NCT07312513

Symptom relief Sponsor: Lohmann & Rauscher Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tests a new two-sided pad (Debrisoft Duo) for cleaning wounds by removing dead tissue. About 104 adults with various wound types (like diabetic ulcers or burns) will be randomly assigned to the new pad or the current one-sided pad. The main goal is to see if the new pad works as well and is just as safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
two-sided debridement pad (device)
What this could lead to
If it works, this could offer a new tool for cleaning wounds more efficiently, potentially improving healing and reducing infection risk.
What could go wrong
This is a small, early-stage study (104 participants) comparing two similar devices. It may not show a meaningful difference, and results may not apply to all wound types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

May 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Patient is legally capable * Patient has signed written informed consent * Presence of one of the following wounds * Venous lower leg ulcer * Arterial ulcer * Diabetic ulcer * Pressure ulcer * Post-operative wound healing by secondary intention * Traumatic wound * Surgical wound * Burn or scald (grade III: after surgical debridement) * Epidermolysis Bullosa * Wound area \>4cm2 * The entire wound area can be displayed on one photo from a distance of 25-30 cm * Covered with at least 30% debris, necrosis, slough, fibrotic tissue Exclusion Criteria: * Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components * Pregnancy or breast feeding * Patient is illiterate * Participation in a interventional clinical trial within the last 14 days and during participation in this study * Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of the study results * severe pain or hyperesthesia in the wound area * history of drug or alcohol abuse * chronic analgesic use (especially opioids) that could influence baseline pain perception * cognitive impairment, which may affect the ability to accurately self-report pain * Use of anaesthesia before the debridment procedure * presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary

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Conditions

The condition(s) this trial relates to.

burn decubitus ulcer epidermolysis bullosa injury Surgical Wound ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arterial ulcers Burns and scalds Diabetic ulcers Epidermolysis bullosa (EB) Postoperative wounds healing by secondary intention Pressure ulcers Surgical wounds Traumatic wounds Venous ulcers

Contacts and locations

Locations

  • Lecran - Centrum Opieki Nad Ranami-Kunickiego

    Wroclaw, 54-616, Poland

  • MIKOMED Sp. z.o.o.

    Lodz, 94-238, Poland

  • MelissaMed Poradnia

    Lodz, 94-102, Poland

  • NZOZ Neuromed M. i M. Nastaj

    Lublin, 20-640, Poland

  • Specjalistyczny Osrodek Leczniczo Badawczy

    Ostróda, 14-100, Poland

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