Development and Clinical Study of Burn Wound Nursing Dressing Based on Sodium Hyaluronate Carbome… (NCT07568600) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Development and Clinical Study of Burn Wound Nursing Dressing Based on Sodium Hyaluronate Carbomer Composite Hydrogel
30 participantsStarted 2026-08-15
Plain-language summary
Development and clinical study of burn wound nursing dressing based on sodium hyaluronate carbomer composite hydrogel
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Partial or full thickness burns requiring split thickness skin grafts Target burn wound size between 10 cm² and 1000 cm² Age ≥ 18 years Ability to read, write, and speak German Provision of voluntary informed consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations Informed consent will be obtained from the patient or from a legal representative if the patient is not able or competent to consent; in such cases, informed consent will also be obtained from the patient when he/she regains competence Women of childbearing potential must test negative on a standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the duration of the study (e.g., oral contraceptive, intrauterine device \[IUD\], intramuscular contraceptive, abstinence)
Exclusion Criteria:
Target wound has exposed hyaline cartilage Connective tissue disorder Previous skin graft failure at target wound site Total burn surface area ≥ 70% Infected target wound Immunosuppression therapy Chronic hemodialysis Steroid use Diabetes (Type I) Allergy or sensitivity to any of the ingredients in Prontosan® Wound Gel X Allergy or sensitivity to chlorhexidine Pregnancy Simultaneous participation in another clinical trial
What they're measuring
1
Graft neo-epithelisation
Timeframe: 50 days. Metric for Summarizing Data: Number and percentage of participants achieving complete neo-epithelisation by Day 50 Mean (±SD) and median (IQR) time to complete neo-epithelisation Rate of neo-epithelisation (% wound closure per day)
Trial details
NCT IDNCT07568600
SponsorThe First Affiliated Hospital of Xinxiang Medical College