Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing
NCT05347654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2025-06-22
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Hospices Civils de Lyon
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-20
- Primary Completion
- 2025-04-29
- Completion
- 2025-04-29
Countries
- France
Study Locations
More Related Trials
-
Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries
NCT00366041 ·Status: TERMINATED ·Phase: PHASE2
-
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
NCT03227146 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Controlled Comparison of a Traditional Dressing Versus a Biologic Dressing Composed of Fetal Fibroblasts and Keratinocytes in Association With a Collagen Matrix on Skin Donor Sites
NCT03334656 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn
NCT03162367 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns
NCT01418482 ·Status: COMPLETED ·Phase: NA
-
Research on the Key Technology of Burn Wound Treatment
NCT03279549 ·Status: UNKNOWN ·Phase: NA
-
StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
NCT03005106 ·Status: COMPLETED ·Phase: PHASE3
-
Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
NCT04839523 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
NCT03229564 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Moist Wound Healing Dressing Alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor Sites
NCT01294254 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks
NCT00675922 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
The Burn Glove Trial - Hand Burn Dressing Pilot
NCT02318056 ·Status: WITHDRAWN ·Phase: NA
-
Comparison Between Early Excision and Grafting Versus Dressing and Delayed Grafting in Deep Burn Mangement.
NCT04965883 ·Status: UNKNOWN ·Phase: NA
-
Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®
NCT00742183 ·Status: COMPLETED ·Phase: NA
-
Efficacy of a Fibrin Sealant in Burn Surgery
NCT00181974 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Endothelial Glycocalyx in the Surgical Resuscitation of Major Burn Patients
NCT06670248 ·Status: RECRUITING
-
Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings
NCT00343824 ·Status: COMPLETED ·Phase: NA
-
A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns
NCT01636362 ·Status: COMPLETED ·Phase: NA
-
Clinical Study of Biocellulose Wound Dressing Containing Silk Sericin and PHMB for STSG Donor Sites
NCT02643680 ·Status: UNKNOWN ·Phase: PHASE2
-
Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting
NCT06488612 ·Status: RECRUITING ·Phase: NA
-
Graft Take and Microbiology in Burns
NCT01301118 ·Status: SUSPENDED
-
Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)
NCT04292054 ·Status: RECRUITING ·Phase: PHASE3
-
Effect of EGF With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream for Treatment of Burn Wound
NCT01553708 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children
NCT03394612 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Autologous Platelets Concentrate and Autologous Thrombin for the Treatment of Deep Burn Trauma
NCT01383187 ·Status: COMPLETED ·Phase: PHASE2/PHASE3