Clinical trial NCT05347654: Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing
Official title: Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing: a Prospective, Controlled, Open, Randomized Multicentre Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns Degree Second
Keywords: Burns Degree Second
detersion,
poly-absorbent dressing
wound healing
skin graft
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of patients with a skin graft performed before D21
timeFrame: At day 21
Secondary outcomes:
measure: Quality of the scar according to health professional
timeFrame: at 1 month, at 3 months, at 6 months, at 12 months
measure: Scar quality according to patient
timeFrame: at 1 month, at 3 months, at 6 months, at 12 months
measure: Complete healing for non-grafted patients
timeFrame: at day 21
measure: Complete healing
timeFrame: at 3 months, at 6 months, at 12 months
measure: Dressing tolerance
timeFrame: at Day 5, Day 6, Day 7, Day 8
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
state: Rhone
Study officials:
References: