Informations générales (source: ClinicalTrials.gov)
Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing: a Prospective, Controlled, Open, Randomized Multicentre Study (HYDRA-B)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
janvier 2023
janvier 2026
05 avril 2025
The management of the local treatment of second-degree burns has an influence on the
healing time and thus on the quality of the healing process. Fibrin detersion optimizes
epidermization and may reduce the need for skin grafting for moderate fibrinous burns.
Optimal treatment at this stage is therefore crucial. Since 1968, silver sulphadiazine
ointment dressings have been used in the management of burns to minimize the risk of
infection. A recent review of the literature suggests that the use of alternative
dressings to silver sulphadiazine ointment, from day 3/4, would have a benefit on wound
healing, but highlights the insufficient level of evidence in current studies. This
probably explains why the prolonged use of silver sulphadiazine dressings remains the
rule in the majority of French centres. In the burns department of Hopital Edouard
Herriot, PLASTENAN® ointment was used as a relay to silver sulphadiazine after one week
of care to promote the detersion of second-degree fibrinous burns. Following the end of
its commercialization in 2014, our nursing team wondered whether an ointment or an
equivalent dressing was available. A clinical study on URGOCLEAN® dressing was conducted
by another team from our university hospital on the detersion of vascular wounds. Given
its positive results,the investigator tested its effectiveness on fibrinous burns. A
cohort of 70 patients (2014-2018) was thus set up by our nursing team: this dressing used
in fibrinous burns showed a low use of skin grafts (2/70), a median healing time of 20
days and an improvement in the quality of the scar. In 2013, a systematic review by the
Cochrane compared seven types of dressings for the treatment of superficial and
intermediate burns, but the URGOCLEAN® dressing, marketed in 2013, was not included.
Considering these findings, the investigator would like to set up a randomized trial to
evaluate a strategy integrating the URGOCLEAN® dressing in the management of
second-degree fibrinous burns.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Edouard Herriot - 69003 - Lyon - Rhone - France | Anne Guier, Nurse | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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