Burns Degree SecondHYDRA-BNCT05347654
Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing
A study testing Local treatment with silver sulphadiazine only and Local treatment with silver sulphadiazine followed by URGOCLEAN® dressing in people with Burns Degree Second, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns Degree Second
- What is being tested?
- Local treatment with silver sulphadiazine only and Local treatment with silver sulphadiazine followed by URGOCLEAN® dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2023to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Burns Degree Second
- Being tested
- Local treatment with silver sulphadiazine only, Local treatment with silver sulphadiazine followed by URGOCLEAN® dressing
- Keywords
- Burns Degree Second, detersion,, poly-absorbent dressing, wound healing, skin graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local treatment with silver sulphadiazine onlyOther
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.
Local treatment with silver sulphadiazine followed by URGOCLEAN® dressingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Local treatment with silver sulphadiazine followed by URGOCLEAN® dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day 21
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: at Day 5, Day 6, Day 7, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start20 Jan 2023
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns Degree SecondStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347654
- Sponsor's protocol ID
- 69HCL20_0076
- Acronym
- HYDRA-B
- Status last verified
- Jun 2025
- First submitted
- 20 Apr 2022
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing: a Prospective, Controlled, Open, Randomized Multicentre Study
- ClinicalTrials.gov ID
- NCT05347654
- Acronym / sponsor ID
- HYDRA-B / 69HCL20_0076
- Conditions
- Burns Degree Second
- Keywords
- Burns Degree Second, detersion,, poly-absorbent dressing, wound healing, skin graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard strategy | Active comparator | Other: Local treatment with silver sulphadiazine onlyLocal 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. |
| Strategy incorporating a poly-absorbent dressing | Experimental | Other: Local treatment with silver sulphadiazine followed by URGOCLEAN® dressingLocal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local treatment with silver sulphadiazine onlyLocal 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. | Other | Standard strategy |
| Local treatment with silver sulphadiazine followed by URGOCLEAN® dressingLocal 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 | Strategy incorporating a poly-absorbent dressing |
Primary outcome
Number of patients with a skin graft performed before D21
Time frame: 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.
5 secondary outcomes
Quality of the scar according to health professional
Time frame: at 1 month, at 3 months, at 6 months, at 12 months
Scar quality according to patient
Time frame: at 1 month, at 3 months, at 6 months, at 12 months
Complete healing for non-grafted patients
Time frame: at day 21
Complete healing
Time frame: at 3 months, at 6 months, at 12 months
Dressing tolerance
Time frame: at Day 5, Day 6, Day 7, Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local treatment with silver sulphadiazine only and Local treatment with silver sulphadiazine followed by URGOCLEAN® dressing in people with Burns Degree Second, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a skin graft performed before D21 (time frame: At day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.