Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing

NCT05347654 | Completed

• 1 other identifier: 69HCL20_0076
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns Degree Second

Keywords

Burns Degree Second; detersion,; poly-absorbent dressing; wound healing; skin graft

Outcome Measures

Primary Outcomes (1)

• Number of patients with a skin graft performed before D21

  The number of patients with a skin graft performed before D21 will be calculated. In case the graft is indicated but the patient refuses it, he will be counted as having had a graft.

  At day 21

Secondary Outcomes (5)

• Quality of the scar according to health professional

  at 1 month, at 3 months, at 6 months, at 12 months

• Scar quality according to patient

  at 1 month, at 3 months, at 6 months, at 12 months

• Complete healing for non-grafted patients

  at day 21

• Complete healing

  at 3 months, at 6 months, at 12 months

• Dressing tolerance

  at Day 5, Day 6, Day 7, Day 8

Study Arms (2)

Standard strategy

ACTIVE COMPARATOR

Local treatment with silver sulphadiazine and tulle from day 0 to day 8. From the 9t h day and until healing, the dressings are made with tulle, every 48 hours.

Other: Local treatment with silver sulphadiazine only

Strategy incorporating a poly-absorbent dressing

EXPERIMENTAL

Local treatment of silver sulphadiazine with tulle from day 0 to day 4, then with URGOCLEAN® dressing every 48h from day 5 to day 8. From the 9th day and until healing, the dressings are made with tulle, every 48 hours.

Other: Local treatment with silver sulphadiazine followed by URGOCLEAN® dressing

Interventions

Local treatment with silver sulphadiazine only OTHER

Local treatment with silver sulphadiazine and tulle from day 0 to day 8 (included). From the 9th day and until healing, the dressings are made with tulle, every 48 hours.

Standard strategy

Local treatment with silver sulphadiazine followed by URGOCLEAN® dressing OTHER

Local treatment of silver sulphadiazine with tulle from day 0 to day 4, then with URGOCLEAN® dressing every 48h from day 5 to day 8. From the 9th day and until healing, the dressings are made with tulle, every 48 hours.

Strategy incorporating a poly-absorbent dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient
• nd 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot

Lyon, Rhone, 69003, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: January 20, 2023
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

FR (1)