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Study on the therapeutic effect of probiotic fermentation supernatant in the treatment of second degree skin burns

Study on the therapeutic effect of probiotic fermentation supernatant in the treatment of second degree skin burns

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112820
Enrollment
Unknown
Registered
2025-11-19
Start date
2023-10-10
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Second degree skin burns

Interventions

Control group:Debridement and dressing change
Experimental Group:Cleaning and dressing change with probiotic fermentation supernatant

Sponsors

Department of Burns, First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18 to 65 years old, gender not limited. 2. According to the latest diagnostic criteria of "Burn Surgery" in China, patients clinically diagnosed with second-degree burns should have injury factors such as flames, hot water, steam, and metals, excluding chemical burns and electrical shocks. The burn duration should be within 48 hours, and the total burn area should not exceed 30% of the total surface area. 3. Where there are relatively independent burn wounds on the trunk and limbs that can be used as target wounds, and the maximum burn area of the target wound does not exceed 2% of the total surface area; 4. The depth of the burn is second-degree burn (shallow second-degree and deep second-degree); 5. Be able to abide by the research procedures and follow-up plans in the scheme; 6. Understand and voluntarily sign the informed consent form approved by the ethics committee.

Exclusion criteria

Exclusion criteria: 1.Patients with other skin diseases (such as skin cancer, atopic dermatitis, psoriasis, furuncles, carbuncles, etc.) in the burned area of the skin; 2. Severe heart disease, myocardial infarction, unstable angina pectoris, chronic heart failure (NYHA grades III and IV), and those with left ventricular hypertrophy shown on electrocardiogram; 3. Patients with a history of drug allergies or allergic constitutions; 4. Patients with combined injuries, inhalation injuries, shock, wound infections, and systemic infections; 5. Patients with immune function suppression after combined burns; 6. Patients with AST or ALT> twice the upper limit of the normal value, or serum total bilirubin > 1.5 times the upper limit of the normal value, or serum creatinine > 1.25 times the upper limit of the normal value, or creatinine clearance rate =11.1mmol/L or fasting blood glucose >=7.0mmol/L at the time of screening and enrollment, and glycated hemoglobin >=6.5%; 9. Patients who need skin grafting; 10. From the time of burn to before enrollment, the subjects had used local medications with national approval numbers such as Compound Five-in-one oil coating, silver sulfadiazine, and recombinant human epidermal growth factor topical preparations on the target wound surface. 11. Those with mental or neurological disorders who are unable to express their will correctly; 12. Women who are breastfeeding, pregnant or preparing for pregnancy; 13. Have participated in other drug clinical research within the past three months; 14. The researchers consider it inappropriate to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Wound healing time;

Secondary

MeasureTime frame
Percentage of wound healing;Pain;Infect;The main manifestations of the wound and surrounding skin include itching, scars, and pigmentation;

Countries

China

Contacts

Public ContactZhang Hongyan

The First Affiliated Hospital of Nanchang University

zhycn2008@163.com+86 371 5671 7052

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026