Management strategy for second-degree burns using a new dressing
Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing: a Prospective, Controlled, Open, Randomized Multicentre Study
This study tests a new dressing for second-degree burns to see if it helps adults heal better and faster compared to the usual silver cream treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon, Rhone) |
| Trial ID | NCT05347654 on ClinicalTrials.gov |
What this trial studies
This study evaluates a management strategy for second-degree fibrinous burns by comparing traditional silver sulphadiazine treatment with a new approach that incorporates URGOCLEAN® dressing after initial treatment. The goal is to optimize wound healing and reduce the need for skin grafts by promoting fibrin detersion. The study focuses on adult patients with specific criteria for burn severity and surface area. Participants will be monitored for healing outcomes and overall treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults with second-degree burns affecting 0.25 to 10% of body surface area and specific fibrinous characteristics.
Not a fit: Patients with facial burns, diabetes, severe vascular insufficiency, or allergies to the dressing components may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing times and reduced need for skin grafts in patients with second-degree burns.
How similar studies have performed: While there is limited evidence supporting the use of alternative dressings, previous studies suggest potential benefits, indicating this approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient * 2nd degree burn with : Affected body surface between 0.25 et 10% Fibrinous surface between 9 and 156 centimeter/meter square (major axis between 3 and 16 centimeter, minor axis of 3 centimeter minimum) One or more non-contiguous fibrinous surfaces * Exudative wet fibrin * Patient treated with silver sulphadiazine between Day 0 and Day 4 * Patient affiliated to a social security scheme * Patient who signed a written consent to participate in the study Exclusion Criteria: * Facial burn * Known diabetic patient * Patient with severe venous and / or arterial insufficiency (obliterating arteriopathy of the lower limbs stage III and IV) * Allergy to one of the components of the URGOCLEAN® dressing (polyacrylate fibers, carboxymethylcellulose, paraffin oil, petroleum jelly) * Person under guardianship or curators * Patient deprived of liberty * Patient for whom silver sulphadiazine is contraindicated (last trimester of pregnancy, lactating woman, allergy to sulfa drugs) * Patient treated with pre-impregnated interfaces (URGOTUL SAG®, IALUSET+® compresses,..) during initial care between Day 0 and Day 4
Where this trial is running
Lyon, Rhone
- Hôpital Edouard Herriot — Lyon, Rhone, France (Recruiting)
Study contacts
- Study coordinator: Anne GUIER, Nurse
- Email: anne.guier@chu-lyon.fr
- Phone: 04.72.11.75.94
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.