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A real-world study to evaluate the efficacy, tolerability, and tolerability of silver-containing dressings based on lipid hydrogel technology in the treatment of superficial partial-thickness burns of the skin

A real-world study to evaluate the efficacy, tolerability, and tolerability of silver-containing dressings based on lipid hydrogel technology in the treatment of superficial partial-thickness burns of the skin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094921
Enrollment
Unknown
Registered
2024-12-30
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Burn

Interventions

Experimental group:Silver-containing dressing based on Technology Lipido-Colloid was used for treatment
Control group:Used clinical silver-containing dressings (such as silver-containing foam dressings,hydrogel silver-containing dressings, and mesh silver-containing

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 1-65 years old (including boundary value), gender is not limited; 2. Recent burns (no more than 48 hours), clinical diagnosis of superficial second-degree burns, depth of burns and scalds diagnosis basis: four degrees and five points, for the area estimation of the wound using the Chinese nine-point method and palm method; 3. The total area of burns and scalds < = 10% TBSA (total body surface area), and the burn surface area is 10-100cm2. Located on the extremities or trunk, the wound is clean and non-infected; Whenever possible, an isolated wound was selected as the test area; 4. The wound has a risk of infection or an indication of infection, and is suitable for treatment with silver-containing dressings; 5. Heat source burns: including thermal fluids (fire, water, soup, oil, etc.); 6. The subject is fully informed and voluntarily or a guardian signs an informed consent form; 7. After verifying the inclusion and exclusion criteria, the subjects will be randomly given the trial number according to the order of the time of screening and qualification, and assigned to the experimental group or the control group.

Exclusion criteria

Exclusion criteria: 1. Patients who have contraindications or allergies to the components of the study dressing (such as hydrocolloids, petroleum jelly or silver salts); 2. Those with clear and severe heart, brain, liver, kidney and other organ dysfunction; 3. Patients with particularly seriously polluted or infected wounds, such as sepsis and bacteremia; 4. Wounds in special locations, which are not easy to be fixed with dressings (such as around the lips) and easy to rub (knees, elbows); 5. Patients with immune dysfunction, HIV infection, or patients who have been treated with radiotherapy, hormones (systemic drugs), chemotherapy, growth factors and immunosuppressive drugs within 1 month; 6. Chemical, electrical, radiographic and other special causes of burns; 7. Critically ill patients with multiple or compound injuries such as inhalation injuries and trauma; 8. Patients with unstable blood glucose control, such as fasting blood glucose >=8.0mmol/L or postprandial blood glucose >=12.0mmol/L; 9. Pregnant or lactating women; or those who have mental disorders and who are unable to express themselves accurately; 10. Patients who are participating in other clinical trials; 11. Other patients who, in the opinion of the investigator, are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
From the beginning of the treatment period to the 10-day observation period, the proportion of patients with complete wound healing in both groups was recorded;

Secondary

MeasureTime frame
Overall wound healing rate;The depth of the wound;Assessment of wound inflammation;Wound pain assessment;Ease of use;

Countries

China

Contacts

Public ContactJi Shizhao

Shanghai Changhai Hospital

shizhaoji2022@163.com+86 186 2158 3165

Outcome results

None listed

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