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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Burns Degree Second
• Intervention / Treatment: Other: Local treatment with silver sulphadiazine only; Other: Local treatment with silver sulphadiazine followed by URGOCLEAN® dressing

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Guier, Nurse; Phone Number: +33 04.72.11.75.94; Email: anne.guier@chu-lyon.fr
• Study Contact Backup: Name: Laurinne MA, CRA; Phone Number: +33 04.72.11.51.69; Email: laurinne.ma@chu-lyon.fr

Study Locations

• France
  • Rhone
    • Lyon, Rhone, France, 69003
      • Recruiting
      • Hopital Edouard Herriot
      • Contact: Anne Guier, Nurse; Phone Number: +33 04.72.11.75.94; Email: anne.guier@chu-lyon.fr
      • Contact: Maria Simona SERBU, MD; Phone Number: +33 04.72.11.75.94; Email: maria.serbu@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of the scar according to health professional	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)	at 1 month, at 3 months, at 6 months, at 12 months
Scar quality according to patient	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)	at 1 month, at 3 months, at 6 months, at 12 months
Complete healing for non-grafted patients	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	at day 21
Complete healing	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.	at 3 months, at 6 months, at 12 months
Dressing tolerance	Any dressing discontinuation related to adverse events, and all tolerance events observed during the treatment period.	at Day 5, Day 6, Day 7, Day 8

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Estimated): January 20, 2026
• Study Completion (Estimated): January 20, 2026

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: wound healing; skin graft; Burns Degree Second; detersion,; poly-absorbent dressing
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Coccidiostats; Sulfadiazine; Silver Sulfadiazine
• Other Study ID Numbers: 69HCL20_0076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No