Debrisoft Duo versus Debrisoft Pad for cleaning chronic and acute wounds
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
This study will test whether Debrisoft Duo works as well and is as safe as Debrisoft Pad for cleaning adult ulcers and other wounds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lohmann & Rauscher Industry-sponsored |
| Locations | 5 sites (Lodz and 4 other locations) |
| Trial ID | NCT07312513 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, parallel-group non-inferiority trial comparing the investigational Debrisoft Duo to the marketed Debrisoft Pad for mechanical wound debridement. Each enrolled patient receives a single debridement with one of the two devices during one study visit, followed by clinical examination and standardized wound photographs. The study will collect performance outcomes and record expected and any unexpected adverse events under routine-use conditions. Data are intended to confirm post-market performance and safety of Debrisoft Duo across a range of wound types.
Who should consider this trial
Good fit: Adults (≥18) with venous, arterial, diabetic, pressure, postoperative, traumatic, surgical wounds, certain burns, or epidermolysis bullosa wounds larger than 4 cm2 with at least 30% visible debris who can give informed consent and attend the study visit.
Not a fit: People who are pregnant or breastfeeding, have a known allergy to product components, are unable to consent or comply, or have wounds smaller than 4 cm2 or with insufficient visible debris are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, patients could have an alternative debridement option that offers similar effectiveness and safety for removing necrotic or sloughy tissue.
How similar studies have performed: Other Debrisoft products and mechanical debridement pads have been used successfully in prior studies, but this head-to-head comparison of the Duo version is being done to confirm comparable performance.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lodz and 4 other locations
- MelissaMed Poradnia — Lodz, Poland (Recruiting)
- MIKOMED Sp. z.o.o. — Lodz, Poland (Recruiting)
- NZOZ Neuromed M. i M. Nastaj — Lublin, Poland (Recruiting)
- Specjalistyczny Osrodek Leczniczo Badawczy — Ostróda, Poland (Recruiting)
- Lecran - Centrum Opieki Nad Ranami-Kunickiego — Wroclaw, Poland (Recruiting)
Study contacts
- Study coordinator: Claudia Feldkamp
- Email: claudia.feldkamp@de.lrmed.com
- Phone: +49 2631 99 7910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.