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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05347654

Collaborator

(none)

310

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns Degree Second	Other: Local treatment with silver sulphadiazine only Other: Local treatment with silver sulphadiazine followed by URGOCLEAN® dressing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

310 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing: a Prospective, Controlled, Open, Randomized Multicentre Study

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Sep 15, 2025

Anticipated Study Completion Date :

Sep 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard strategy 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 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.
Experimental: Strategy incorporating a poly-absorbent dressing 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 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.

Arm

Intervention/Treatment

Active Comparator: Standard strategy

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

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.

Experimental: Strategy incorporating a poly-absorbent dressing

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

Outcome Measures

Primary Outcome Measures

Number of patients with a skin graft performed before D21 [At day 21]
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.

Secondary Outcome Measures

Quality of the scar according to health professional [at 1 month, at 3 months, at 6 months, at 12 months]
The quality of the scar according to the professional will be assessed using the total POSAS (Patient and Observer Scar Assessment Scale ) score. Score from 7 (best score) to 70 (worst score)
Scar quality according to patient [at 1 month, at 3 months, at 6 months, at 12 months]
The quality of the scar according to the patient will be assessed using the total POSAS (patient) score. Score from 7 (best score) to 70 (worst score)
Complete healing for non-grafted patients [at day 21]
Complete healing for non-grafted patients assessed by the number of patients with epidermization defined by total wound coverage with pink epithelium and dressing discontinuation
Complete healing [at 3 months, at 6 months, at 12 months]
The number of patients for whom scar healing is observed will be calculated. Scar healing is defined by: dressing discontinuation, and scar maturation (cessation of compression), and clinical follow-up discontinuation.
Dressing tolerance [at Day 5, Day 6, Day 7, Day 8]
Any dressing discontinuation related to adverse events, and all tolerance events observed during the treatment period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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